Canada to Require Health Warnings on Individual Cigarettes
On World No Tobacco Day, Canada’s Minister for Mental Health and Addictions and Associate Minister of Health Carolyn Bennett announced the country will soon require health warnings to be printed directly on individual cigarettes.
According to the announcement, the country’s new Tobacco Products Appearance, Packaging, and Labelling Regulations are part of Canada’s continued efforts to help adults who smoke to quit, to protect youth and non-tobacco users from nicotine addiction, and to further reduce the appeal of tobacco.
“Tobacco use continues to kill 48,000 Canadians each year,” Ms. Bennett said in the announcement. “We are taking action by being the first country in the world to label individual cigarettes with health warning messages. This bold step will make health warning messages virtually unavoidable, and together with updated graphic images displayed on the package, will provide a real and startling reminder of the health consequences of smoking. We will continue to do whatever it takes to help more people in Canada stop smoking and help young people to live healthy tobacco-free lives.”
The new regulations will be in force beginning August 1, 2023, and will be implemented through a phased approach that will see most measures on the Canadian market within the year. Other measures in the regulations include strengthening and updating health-related messages on tobacco product packages; extending the requirement for health-related messaging to all tobacco product packages; and implementing the periodic rotation of message.
US FDA Approves New Drug Application for Pemetrexed Injection in NSCLC, MPM
The US Food and Drug Administration (FDA) recently approved a New Drug Application (NDA) for PEMRYDI RTU, a pemetrexed disodium injection. This product is the first ready-to-use presentation of pemetrexed for injection and does not require reconstitution, dilution, or refrigeration. The injectable will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,000mg/100mL.
PEMRYDI RTU is indicated, in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK aberrations and for initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
US FDA Grants Priority Review of Repotrectinib for Advanced ROS1+ NSCLC
The FDA recently granted priority review to a new drug application for repotrectinib, a next-generation TKI. The application was based on results from the TRIDENT-1 trial, which showed high response rates and durable responses with repotrectinib in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
If approved, repotrectinib could be an option for TKI-naïve patients and a could provide a potential first-in-class option for patients with ROS1-positive NSCLC who have been previously treated with a TKI, and for whom there are currently no approved targeted therapies available in the US, according to a press release from Bristol Myers Squibb.
TRIDENT-1 is a phase 1/2 open-label, global, multi-center, first-in-human clinical trial evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of repotrectinib in patients with advanced solid tumors, including NSCLC.