Food and drug administration Approves Tisagenlecleucel in most as First Approved Gene Therapy

Jason M. Broderick

Officials using the Food and drug administration have issued a historic approval from the first Chimeric Antigen Receptor (Vehicle) T-Cell Therapy to be shown within the U . s . States. Tisagenlecleucel (Kymriah, Novartis) continues to be approved to treat patients as much as 25 years old with B-cell precursor acute lymphoblastic leukemia (ALL) that’s refractory or perhaps in second or later relapse.

Your application from the immunocellular therapy follows the recommendation from the FDA’s Oncologic Drugs Advisory Committee (ODAC) which voted 10- inside a committee meeting in This summer to recommend approval of tisagenlecleucel for pediatric ALL.

“We’re entering a brand new frontier in medical innovation having the ability to reprogram a patient’s own cells to fight a deadly cancer,” Food and drug administration Commissioner Scott Gottlieb, MD, stated inside a statement. “New technologies for example gene and cell therapies hold on the possibility to change medicine and make an inflection reason for our capability to treat as well as cure many intractable illnesses. In the Food and drug administration, we’re dedicated to helping expedite the event and overview of groundbreaking treatments that have the possibility to become existence-saving.”

The main effectiveness analysis took it’s origin from phase II is a result of CCTL019B2202 (B2202), just one-arm, worldwide trial of 63 patients who received just one dose of tisagenlecleucel. The targeted dose of every tisagenlecleucel infusion was 2. to five. x 106 kg for patients ≤50 kg and 1. to two.5 x 108 for individuals >50 kg.

Overall remission rate was 82.5% (95% CI, 70.9-91.) in treated subjects. Forty patients (63%) had complete remission (CR) and 12 (19%) had complete remission with incomplete hematologic recovery (CRi).

All patients who’d CR or CRi were connected with negative minimal residual disease status within the bone marrow.

Investigators figured that tisagenlecleucel was connected with clinically significant remissions. Believed relapse-free rate among responders at month 6 was 75.4% (95% CI, 57.2-86.7). Median time period of response wasn’t arrived at in a median follow-from 4.8 several weeks.

Eleven patients who’d CR+ CRi relapsed after tisagenlecleucel just before data cut-off and before any new cancer therapy. Two other patients relapsed after receiving both tisagenlecleucel and new cancer therapy. From the 52 patients who’d CR+ CRi, 29 remained as in remission in the last assessment prior to the data cutoff.

Median event-free survival (EFS) is not arrived at in a median follow-from 5.6 several weeks. Of 63 patients evaluable for effectiveness, 20 (31.7%) had an EFS event. In a median follow-from 6.9 several weeks, overall survival is not arrived at.

60-eight patients were incorporated within the safety review.

The most typical, >5%, serious adverse occasions (AEs) recorded within the study were cytokine release syndrome (CRS), febrile neutropenia, hypotension, acute kidney injuries, fever, and hypoxia. Thirty-two patients (47%) experienced grade 3/4 CRS, and median duration was 8 days. There have been no deaths connected with CRS.

Ten patients (15%) experienced grade 3 neurotoxicity, and 18 experienced grade 3/4 infections within 8 times of infusion. Three patients died within two months of infusion because of infections.

The Food and drug administration approved a danger Evaluation and Minimization Strategy (REMS) for tisagenlecleucel. Based on Novartis, the maker from the Vehicle T-cell therapy, the REMS program will educate medical professionals concerning the risks which may be connected using the treatment.

“Kymriah is really a first-of-its-kind treatment approach that fills an essential unmet requirement for children and youthful adults with this particular serious disease,” Peter Marks, MD, PhD, director from the FDA’s Center for Biologics Evaluation and Research, stated inside a statement. “Not only does Kymriah provide these patients with a brand new treatment option where limited options existed, however a treatment option which has proven promising remission and survival rates in numerous studies.Inches

Inside a separate action, the Food and drug administration has additionally expanded your application of tocilizumab (Actemra) to treat Vehicle T-cell–induced severe or existence-threatening CRS in patients 2 years old or older. Your application is dependant on data demonstrating that in numerous studies of Vehicle T-cell therapy, patients who received tocilizumab had complete resolution of CRS within 2 days following one or two doses from the treatment.

“Until today, there has not been an Food and drug administration-approved treatment to handle severe cytokine release syndrome connected with Vehicle T-cell therapy, that is marked with a rapid onset and may cause existence-threatening complications,” Sandra Horning, MD, chief medical officer and mind of worldwide product at Genentech (Roche), the maker of tocilizumab, stated inside a statement. “Today’s approval of Actemra/RoActemra for CRS provides physicians by having an important tool to assist manage this potentially existence-threatening side-effect.Inches

This short article initially made an appearance on onclive.com:  

For additional on oncology treatments, please see the video below. 

 

‘Reprogrammed’ Stem Cells Fight Parkinson’s Disease in Apes

Scientists have effectively used “reprogrammed” stem cells to revive functioning cognitive abilities in apes, raising hopes the process might be used later on to assist patients with Parkinson’s disease.

Since Parkinson’s is because too little dopamine produced by cognitive abilities, scientific study has lengthy wished to make use of stem cells to revive normal manufacture of the natural chemical chemical.

Now, the very first time, Japanese scientific study has proven that human caused pluripotent stem cells (iPS) could be administered securely and effectively to deal with primates with signs and symptoms from the debilitating disease.

So-known as iPS cells are created by removing mature cells from your individual — frequently in the skin — and reprogramming these to become embryonic stem cells. They are able to then be coaxed into dopamine-producing cognitive abilities.

The scientists from Kyoto College, a global-leader in iPS technology, stated their experiment established that this method may potentially be utilized for that clinical management of human patients with Parkinson’s.

Additionally to boosting dopamine production, the tests demonstrated improved movement in affected apes with no tumors within their brains not less than 2 yrs.

A persons iPS cells utilized in the experiment labored whether or not they originated from healthy individuals or Parkinson’s disease patients, japan team reported within the journal Nature on Wednesday.

“This really is very promising research demonstrating that the safe and impressive cell therapy for Parkinson’s could be created within the lab,” stated Tilo Kunath from the MRC Center for Regenerative Medicine, College of Edinburgh, who had been not active in the research.

The next phase is to test the therapy inside a first-in-human medical trial, which Jun Takahashi of Kyoto College told Reuters he wished to begin through the finish of 2018.

Any prevalent utilisation of the new treatments are still a long time away, however the studies have considerably reduced previous uncertainties about iPS-derived cell grafts.

The truth that these studies uses iPS cells rather human embryonic stem cells means the therapy could be acceptable in countries for example Ireland and far of South America, where embryonic cells are banned.

Excitement concerning the commitment of stem cells has brought to countless medical facilities arising all over the world claiming so that you can repair broken tissue in conditions for example ms and Parkinson’s.

Although some treating cancer and skin grafts happen to be approved by regulators, a number of other potential therapies are just at the begining of-stage development, prompting an alert recently by health professionals concerning the risks of “stem-cell tourism.”

Bill would regulate middlemen who help set Calif. drug prices

Among the bills within the California legislature made to address high prescription medication costs would take are designed for the middlemen who negotiate pharmaceutical prices by getting them underneath the state’s regulatory purview.

Pharmacy benefit managers would be the go-betweens who negotiate drug prices with manufacturers with respect to health insurers. Additionally they write the formularies that list which drugs are handled by a specific health plan.

AB 315, created by Assemblyman Jim Wood (D-Healdsburg), will need pharmacy benefit managers to join up and submit details about drug costs, rebates and charges towards the condition Department of Managed Healthcare. It’s passed the Senate and it is now within the Set up.

“I wish to realize that the customer is really getting what they’re having to pay for and also at the finish during the day the consumer is really recognizing an advantage from that,” stated Wood. “That’s really unclear at this time.Inch

The Pharmaceutical Care Management Association, the trade group representing pharmacy benefit managers states the balance would hamper remarkable ability to barter affordable prices, which may finish up resulting in greater drug costs. The Association states regulation would jeopardize trade secrets.

“It is also counter-productive since employers, unions, and plans already figure out what information they need disclosed before selecting from among different [pharmacy benefit managers], Association President and CEO Mark Merritt stated via email. “A 1-size-fits-all mandate would cut back payers’ choices and worsen, not better, for consumers.” 

The California Department of Finance also opposes the balance, in line with the costs connected with applying new rules. The finance department estimates the measure would cost the Department of Managed Care around $900,000 annually.

The balance is among four moving with the legislature targeted at high drug prices. For Wood, Senate bill 17, an invoice that will impose transparency in manufacturer’s drug prices, goes hands-in-hands together with his legislation.

“If these industries do everything around the up or more, they do not have anything to fear from all of these bills,” stated Wood. “These bills will undoubtedly provide information and everyone is going to be happy, however the push-back continues to be really, really strong, which makes me suspicious, to be honest.Inch

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US Clears First ‘Living Drug’ for Tough Kind of Leukemia

Opening a brand new era in cancer care, the Fda on Wednesday approved the very first treatment that genetically engineers patients’ own bloodstream cells into a military of assassins to find and destroy childhood leukemia.

The Vehicle-T cell treatment produced by Novartis Pharmaceuticals and also the College of Pennsylvania may be the first kind of gene therapy hitting the U.S. market — and something inside a effective but costly wave of custom-made “living drugs” being tested against bloodstream cancers and a few other tumors, too.

Food and drug administration known as your application historic.

“This can be a brand-new method of treating cancer,” stated Dr. Stephan Grupp of Children’s Hospital of Philadelphia, who treated the very first child with Vehicle-T cell therapy — a woman who’d been near dying however is cancer-free for 5 years and counting. “That’s enormously exciting.”

Novartis stated it might charge $475,000 for that treatment, produced from scratch for each patient. But, the organization stated there’d not be any charge when the patient did not show an answer inside a month.

Vehicle-T treatment uses gene therapy techniques to not fix disease-causing genes but to turbocharge T cells, defense mechanisms soldiers that cancer too frequently can evade. Researchers filter individuals cells from the patient’s bloodstream, reprogram these to harbor a “chimeric antigen receptor” that zeroes in on cancer, and also be vast sums of copies. Came back towards the patient, the revved-up cells can continue multiplying to battle disease for several weeks or years.

Different path

It is a different method to harness the defense mechanisms than popular immunotherapy drugs known as “checkpoint inhibitors” that treat a number of cancers by enhancing the body’s natural T cells better place tumors. Vehicle-T cell therapy gives patients more powerful T cells to achieve that job.

“We are entering a brand new frontier in medical innovation having the ability to reprogram an individual’s own cells to fight a deadly cancer,” stated Food and drug administration Commissioner Scott Gottlieb.

This primary utilization of Vehicle-T therapy targets patients anxiously ill having a common pediatric cancer — acute lymphoblastic leukemia, or ALL — that strikes greater than 3,000 children and youthful adults within the U.S. every year. Some survive, about 15 % relapse despite today’s best treatments, as well as their prognosis is bleak.

Inside a key study of 63 advanced patients, 83 percent entered remission. You need to note, however, it’s not obvious how lengthy that benefit lasts: Some patients did relapse several weeks later, and also the others are still being tracked to determine the way they fare within the lengthy term.

Still, “a much greater number of patients get into remission with this particular therapy than other things we have seen up to now with relapsed leukemia,” stated Dr. Ted Laetsch from the College of Texas Southwestern Clinic, among the study sites. “I would not say we all know without a doubt the number of is going to be cured yet with this therapy. There is really a hope” that many will be.

Most sufferers endured negative effects that may be grueling, even existence-threatening. An immune overreaction known as “cytokine release syndrome” can trigger high fevers, plummeting bloodstream pressure as well as in severe cases organ damage, requiring additional care to tamp lower individuals signs and symptoms without blocking cancer attack. Also Wednesday, the Food and drug administration designated cure for individuals negative effects.

“This really is outstanding technology,” stated Dr. Mikkael Sekeres from the American Society of Hematology. But, he cautioned, “it is not a cure all.”

Possible resistance

Among concerns, sometimes leukemia can be cultivated resistance, and often patients worsen while awaiting their new cells, stated Sekeres, who directs the Cleveland Clinic’s leukemia program and wasn’t associated with Vehicle-T testing.

“Regrettably, leukemia grows so quickly that it may evade the smartest in our technologies,” he added.

For many patients, the brand new Vehicle-T therapy might replace bone marrow transplants that are more expensive than $500,000, noted Grupp, who brought the Novartis study.

“I’d rather not be an apologist for top drug prices within the U.S.,” Grupp stressed. But when it is the last treatment they require, “this is a really significant one-time purchase of their wellness, particularly in kids who’ve an entire lifetime in front of them.”

Initially, Novartis’ Vehicle-T version — to become offered underneath the brand Kymriah (kihm-REYE’-eh) — is going to be available only through certain medical facilities specifically trained to handle sophisticated therapy and it is negative effects. Patients’ collected immune cells is going to be frozen and shipped to some Novartis factory in Nj that produces each dose, a procedure the organization states must take around three days.

Although this first utilization of Vehicle-T therapy targets merely a couple of hundred U.S. patients annually — relapsed ALL patients as much as age 25 — it’s being tested like a strategy to thousands more. Kite Pharma’s similar Vehicle-T brand, produced by the nation’s Cancer Institute, is anticipated to win approval later this season to deal with aggressive lymphoma, and Juno Therapeutics along with other information mill studying their very own versions against bloodstream cancers including multiple myeloma.

Scientists round the country also are attempting to make Vehicle-T therapies that may fight more prevalent solid tumors for example brain, breast or pancreatic cancers — a harder next thing.

Erectile dysfunction renovation will open doorways to higher patient flow


Our Tales

Erectile dysfunction renovation will open doorways to higher patient flow

Toronto, August 30, 2017

By Kate Manicom

A rendering of the entrance and ambulance bay of the new Slaight Family Emergency Department, which is currently under construction
A rendering from the entrance and ambulance bay from the new Slaight Family Emergency Department, that is presently being built. (Rendering by NORR Architects)

All patients coming at St. Michael’s Emergency Department come using it . doorways, when they have been a damaged ankle and have been seriously hurt inside a collision. When it’s busy, the present configuration is challenging for patients as well as for staff.

“Patients who arrive by themselves aren’t sure who to speak with or what to do, creating bottlenecks in the registration desk,” stated Karin Wells, an authorized nurse in St. Michael’s Erectile dysfunction. “Patients on stretchers who’re introduced in by Toronto Paramedic Services can obstruct our view in to the waiting area, which makes it difficult to monitor individuals who’re sitting down and might need to be viewed rapidly. Additionally, it presents privacy challenges to possess our trauma patients transferred with the area, and could be upsetting for other patients and family members who’re browsing exactly the same space.”

Included in the renovation and growth of the Erectile dysfunction, the ambulance bay, triage and patient waiting area is going to be reconfigured to produce better flow for clinical staff and first responders, along with a better experience for patients and themselves. A vital change is creating two separate entrances for patients who’re transported by Toronto Paramedic Services as well as for individuals who arrive by themselves.

The brand new triage area is going to be bigger, with better sightlines for staff. The registration desk is going to be positioned across in the door, making the triage process more obvious for patients. Outdoors, a brand new drop-off position for cars and taxis is going to be produced on Shuter Street.

      “The nature from the Erectile dysfunction is extremely demanding to start with, and triage is frequently a patient’s first impression from the hospital. Getting an inviting space that’s simpler to navigate will assist you to put patients and themselves comfortable.Inches
– Natasha Cummings, an authorized nurse in St. Michael’s Erectile dysfunction

“The nature from the Erectile dysfunction is extremely demanding to start with, and triage is frequently a patient’s first impression from the hospital,” stated Natasha Cummings, an authorized nurse within the Erectile dysfunction. “Having an inviting space that’s simpler to navigate will assist you to put patients comfortable.Inches

The ambulance bay, which can now accommodate only 3 to 4 vehicles, may also be expanded. Growing dedicated parking for ambulances will assist you to ensure they don’t hamper traffic round the hospital and can bring patients nearer to a healthcare facility doorways. A garage doors will be included to the bay to supply elevated security when needed.

The general renovations towards the Erectile dysfunction will double its size and include more patient treatment areas, including 24-7 diagnostic imaging within the department along with a bigger ambulatory area. It will likewise incorporate a fully renovated that has been enhanced trauma area along with a new, dedicated mental health area, physically separated from all of those other Erectile dysfunction, staffed by specifically educated crisis workers and medical service providers.

Erectile dysfunction staff, like Cummings, appear at first sight looking forward to the alterations. “If only we’d a magic wand to get it done immediately!”

About St. Michael’s Hospital

St. Michael’s Hospital provides compassionate choose to all who enter its doorways. A healthcare facility offers outstanding medical education to future medical professionals in additional than 29 academic disciplines. Critical care and trauma, cardiovascular disease, neurosurgery, diabetes, cancer care, proper care of the destitute and global health are some of the Hospital’s recognized special areas of practice. With the Keenan Research Center and also the Li Ka Shing Worldwide Healthcare Education Center, which from the Li Ka Shing Understanding Institute, research and education at St. Michael’s Hospital are recognized making an effect all over the world. Founded in 1892, a healthcare facility is fully associated with the College of Toronto.

Cancer of the breast biosimilar approval delayed as US Food and drug administration reviews more information by Biocon, Mylan

The extension follows Biocon’s withdrawal of its application for approval for trastuzumab and pegfilgrastim, a drug used to fight infections in chemotherapy patients.The extension follows Biocon’s withdrawal of their application for approval for trastuzumab and pegfilgrastim, a medication accustomed to fight infections in chemotherapy patients.
NEW DELHI: The United States Fda (Food and drug administration) has delayed by three several weeks its decision on whether or not this will provide Biocon and Mylan’s cancer of the breast biosimilar drug although it reviews more information posted through the companies. Your application was earlier expected on September 3.

US Food and drug administration has notified Mylan it’ll extend the prospective action date for his or her use of the drug, trastuzumab, to December 3, Biocon told the Bombay Stock Market (BSE) after markets closed on Wednesday. This is needed to examine some “clarificatory” information posted towards the regulator included in the application review process, a Biocon spokesperson stated.

Biocon and Mylan have together developed the trastuzumab biosimilar, that is a copy of the complex biologic drug produced by Swiss biotech giant Roche.

“This three month extension doesn’t have effect on the anticipated timetable for commercialisation of the product in america,Inch the spokesperson mentioned.

The extension follows Biocon’s withdrawal of their application for approval for trastuzumab and pegfilgrastim, a medication accustomed to fight infections in chemotherapy patients, in Europe regulatory government bodies there searched for a re-inspection of their facility of these products. In This summer, France’s drug regulator had found too little Good Manufacturing Practices (GMP) in the facility that made these drugs.

Yet, the Bengaluru-based firm stated the united states FDA’s decision to increase its target action date for that trastuzumab application isn’t a consequence of any quality-related concerns.

“The extension from the target action date is from the overview of the clarificatory information searched for included in the application. This post is not associated with any GMP audit observations at our manufacturing facilities,” a business spokesperson told ET.

After it withdrew its application in Europe, Biocon told BSE it was area of the European Medicines Agency’s (EMA) procedural needs associated with re-inspections.

In This summer, US FDA’s Oncology Drugs Advisory Committee (ODAC) had unanimously suggested your application of Biocon and Mylan’s trastuzumab biosimilar.

Share prices of Biocon on BSE closed .78% greater at Rs 344.10 a bit on Wednesday, as the benchmark Sensex ended .82% greater.

Study: Metropolitan areas and firms Get Together to Tackle Urban Water Crises

With rising urban populations and ever scarcer water supplies, metropolitan areas and firms are teaming as much as invest vast amounts of dollars in water management projects, a study stated on Tuesday.

About 2 thirds of metropolitan areas from London to La will work using the private sector to deal with water and global warming stresses with 80 metropolitan areas seeking $9.5 billion of investment for water projects, based on a study through the Carbon Disclosure Project (CDP), a non-profit ecological research group.

Water investment possibilities are finest in South America, with Quito in Ecuador seeking $800 million to handle its supply of water, including building three hydropower stations and clearing up its contaminated rivers and streams.

City in India prepares for future

The metropolitan areas most worried about their supply of water lie in Asia and also the Off-shore, the report found, with serious risks also identified in Africa and South America.

The important thing issues for metropolitan areas include declining water quality, water shortages and flooding.

The Indian town of Chennai faced extreme floods in 2015 which wiped out hundreds and left survivors without use of water that is clean, while companies were also seriously disrupted.

The town has become purchasing boosting its resilience to future water crises, with water conservation education, creating a storm water management system and new infrastructure.

“We are seeing critical shifts in leadership from metropolitan areas and firms as a result of the real threat of flooding, for instance, to local economies,” stated Morgan Gillespy, mind of CDP’s Water Program.

Global warming is yet another underlying threat to any or all metropolitan areas with a rise in extreme weather occasions from droughts to floods, with metropolitan areas in The United States more concerned than individuals in Europe, the report found.

Tropical Storm Harvey, pounding the U.S. Gulf Coast, has wiped out a minimum of eight people, brought to mass evacuations and paralyzed Houston, the 4th most-populous U.S. city.

The storm is probably associated with global warming, stated the U.N. weather agency.

Information mill also worried about the results of global warming on water supplies, with $14 billion water impacts for example lack of production as reported by companies this past year, the report found.

United nations predicts global water shortfall

The Un predicts a 40 % shortfall in global supply of water by 2030, while global demand is placed to improve by 55 percent because of growing domestic use, manufacturing and electricity generation.

“From our use metropolitan areas all over the world, water has consistently show up like a key resilience challenge,” stated Claire Bonham-Carter, Principal and City Resilience Lead at AECOM, a worldwide infrastructure firm and partner around the report.

“Many of these, no matter size, from Mexico City, Mexico to Berkeley, California, are addressing both lengthy-term supply of water issues in addition to chronic urban flooding.”

Should movies with smoking have an ‘R’ rating?

Pointing towards the U.S. Surgeon General’s conclusion that depictions of smoking in movies lead youthful individuals to adopt the fatal habit, 17 leading public medical and health groups are contacting the show industry to provide an R-rating to the movie featuring tobacco imagery.

The particular groups, such as the American Academy of Pediatrics, the Ama and also the American Cancer Society, demand the Movie Association of the usa implement this transformation for those movies posted for classification after June 1, 2018.

The Movie Association of the usa declined to comment.

The groups’ letter endorses the advice inside a This summer report in the Cdc and Prevention that found the entire quantity of occasions that cigarettes and tobacco products were pictured in top-grossing movies elevated 72 percent from 2010 to 2016. The CDC also found a 43 percent rise in scenes featuring tobacco in PG-13 films in that period.

The amount of G, PG, and PG-13 movies with tobacco occurrences had continuously declined between 2005 and 2010, the report states.

The CDC report supports the thought of assigning an R rating to the movie with smoking scenes, “unless of course the portrayal is of actual historic figures who smoked, a documentary, or maybe the portrayal includes the side effects of tobacco use.”

The six major film studios have policies to lessen depictions of tobacco use within youth-rated films, and individuals likely led to the decrease in the amount of scenes featuring tobacco between 2005 and 2010, based on the CDC.

Altria, which owns Philip Morris USA, the biggest tobacco company in the united states, states it doesn’t want its brands appearing on the watch’s screen, acknowledging a causal relationship between depictions of smoking in movies and the chance of youthful people following a habit.

That position doesn’t go quite so far as U.S. Surgeon General Dr. Regina Benjamin did this year, when she figured that there’s sufficient evidence to declare “that there’s a causal relationship between depictions of smoking within the movies and also the initiation of smoking among youthful people.”

Altria states it contacted minor and major movie studios in 2008 to cause them to become take additional steps to get rid of smoking scenes in movies fond of youth.

“Today whenever we become familiar with a film depicts our brands, we contact movie studio executives,” Altria states in a statement on its website. “On several occasions, the California Attorney General has told us that our brands was portrayed inside a film. During these situations, we contacted the particular studio executives and requested these to remove our brands from current and future productions and marketing materials.”

The thought of giving movies with smoking an R-rating continues to be debated for a long time. The CDC recommended it this year.

Seven years later, the CDC finds that progress in lessening depictions of smoking in youth-rated movies has stalled. It states that although there have been less top-grossing films depicting tobacco use within 2016 in contrast to 2010, the amount of occasions these occurrences happened elevated, effectively concentrating pictures of tobacco use into less movies.

The report is dependant on research conducted by Breathe California of Sacramento-Emigrant Trails, by which trained monitors counted all tobacco occurrences within the top 10-grossing movies in almost any calendar week.

A brand new incident was counted every time a tobacco product discontinued screen after which returned on the watch’s screen another actor was proven having a tobacco product or perhaps a scene altered and also the new scene contained using tobacco. Tobacco was understood to be cigarettes, cigars, pipes, shisha, electric cigarettes and tobacco products and electric cigarettes.

“Because the industry’s progress stopped, major studios and independent producer-distributors have released 210 top-grossing, youth-rated U.S. films featuring greater than 6,000 tobacco occurrences, delivering 60.5 billion tobacco impressions to audiences in U.S. theaters alone,” the letter states.

The letter continues: “When the industry had simply ongoing reducing tobacco content in the youth-rated films in the pace it did between 2005 and 2010, all youth-rated films could have been entirely smoke-free by 2015.”

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