The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions on treatments for amyotrophic lateral sclerosis (ALS) and lung cancer. Biogen's treatment, QALSODY (tofersen), specifically targets a rare, genetic form of ALS in adults with a specific gene mutation. Meanwhile, Merck announced a CHMP recommendation for its lung cancer treatment for certain patients. In the United States, the FDA has withdrawn approval for Oncopeptides' cancer drug, Pepaxto, for multiple myeloma patients, marking the first accelerated approval withdrawal under the FDORA expedited procedures. The decision followed an ODAC vote of 14-2 against keeping its accelerated approval in 2022, with FDA's Peter Marks signing off on the withdrawal.
FDA Uses New Powers to Remove Pepaxto Cancer Drug From US Market https://t.co/Xx2wsuiA70
Check out the latest FDA Roundup, our at-a-glance summary of agency updates: https://t.co/XOfOOAQi96 Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain… https://t.co/xxIFKvVJER
A European Medicines Agency committee recommended that the label for Legend Biotech and Johnson & Johnson’s CAR-T Carvykti be expanded to multiple myeloma patients as a second-line option, Legend announced Friday morning. https://t.co/48VlOdm2eg
FDA formally pulls Oncopeptides' cancer drug after prolonged back-and-forth - (ODAC voted 14-2 against keeping its AA in 2022) Peter Marks signs off on it, says Pepaxto cannot remain marketed while the pull is ongoing - https://t.co/v4DKU8Ejgi
Oncopeptides' Pepaxto reaches end of the line in US after FDA yanks approval https://t.co/iNNnKuaj7o
$ONCO announces @US_FDA has ordered multiple myeloma drug Pepaxto withdrawn following company's appeal, marking first accelerated approval withdrawal under FDORA expedited procedures
ALS-Linked Protein Could Be Target for Neurodegenerative Disease Therapies Scientists say that a protein called NPTX2 could be a viable target for therapies that treat ALS and similar neurodegenerative diseases. Learn more: https://t.co/Iz4a1nxuAn https://t.co/kv1GlIAAvv
$BIIB QALSODY (tofersen), the First Therapy to Treat Rare, Genetic Form of ALS, Receives Positive Opinion from CHMP
We’ve received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for our treatment for amyotrophic lateral sclerosis (#ALS) in adults who have a specific gene mutation. Learn more about this news: https://t.co/BMl83MOB1e https://t.co/U2enSmz3Nb
Today, we announced a CHMP opinion recommending approval of our treatment for certain patients with #lungcancer. Learn more: https://t.co/gU0tS3dmQB https://t.co/ztQ1NYbB61