Tag Archive for: melanoma

Since Roche’s Zelboraf gained (vemurafenib) FDA approval in 2011, significant strides have been made in BRAF-targeted cancer therapies, underscoring the significance of combating BRAF mutations in melanoma. Against this backdrop, Pfizer’s Braftovi (encorafenib) is positioned to secure a dominant 42% share of the BRAF inhibitors market for melanoma by 2028, underscoring its pivotal role in cancer therapy.

For the first time, the 300,000 U.S. primary care physicians can now be equipped to provide quantitative, point-of-care testing for all types of skin cancer.

Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.

A combination of Merck’s blockbuster cancer drug Keytruda and an mRNA vaccine from Moderna has demonstrated positive results at the three-year stage in a Phase IIb study of patients with resected high-risk melanoma following complete resection.

Global recruitment for the trial has begun, with the first patients being enrolled in Australia, the companies said, adding that the study would take place in more than 25 countries around the world.

The Inflation Reduction Act could put an end to blockbuster runs like that of Merck’s Keytruda. In the meantime, the drug keeps picking up more indications and positive clinical results.

Adding an experimental mRNA-based vaccine from Moderna and Merck reduced the risk that the most deadly skin cancer would spread by 65% over treatment with an immunotherapy alone in a midstage trial, the companies reported today.

The company announced its experimental personalized mRNA skin cancer vaccine in combination with Merck & Co Inc.’s drug Keytruda has received breakthrough therapy designation from U.S. regulators as an additional treatment for high risk patients.

Iovance Biotherapeutics announced the FDA’s Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.

Bristol Myers Squibb announced Thursday that its blockbuster checkpoint inhibitor Opdivo hit the primary endpoint in the Phase III CheckMate-76K trial for a particularly intractable form of melanoma.