Swiss drugmaker Novartis said the company’s investigational spartalizumab immuno-oncology drug mixed with the approved medicines Tafinlar and Mekinist failed in a late-stage trial for a type of advanced skin cancer.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Wrapping up June and ahead of the July 4 holiday, the U.S. Food and Drug Administration has a busy two-week period coming up for drug approval reviews.
Paris-based Sanofi and Tarrytown, New York-based Regeneron Pharmaceuticals announced topline data for the companies’ pivotal Phase II trial of the PD-1 checkpoint inhibitor Libtayo (cemiplimab) in advanced basal cell carcinoma patients that had progressed on or could not tolerate previous hedgehog pathway inhibitor therapies.
Merck’s Keytruda (pembrolizumab) received a rejection from the U.S. Food and Drug Administration for each of six supplemental Biologics License Applications to update the dosing frequency of the checkpoint inhibitor to include every-six-weeks administration.
A late-stage trial testing a combination of Bristol-Myers Squibb Co.’s cancer drugs missed a main goal of preventing skin cancer from recurring in a certain group of patients.
Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
The European Commission granted conditional marketing authorization for Libtayo (cemiplimab) for treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Spending time in the sun without protection increases the risk of melanoma, but the potentially deadly skin cancer can occur even on sites with minimal sun exposure, doctors warn.
Merck & Co. Inc.’s blockbuster anti-PD-1 immunotherapy Keytruda failed a late-stage trial’s main goals of slowing disease progression and extending the life of patients with a common type of liver cancer.