Following a cumbersome process, the U.S. FDA is withdrawing its accelerated approval for Truseltiq (infigratinib) as a second-line treatment for patients with unresectable locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
Becoming the first type II RAF inhibitor for relapsed or refractory BRAF-altered pediatric low-grade glioma, Day One Biopharmaceuticals Inc.’s Ojemda (tovorafenib, DAY-101) gained U.S. FDA accelerated approval on April 23, a week earlier than its expected PDUFA date, bringing the Brisbane, Calif.-based company a rare pediatric disease priority review voucher.
The U.S. FDA thinks using minimal residual disease as an endpoint for accelerated approval in new therapies to treat multiple myeloma (MM) might just be an idea whose time has come. The FDA now wants to know what its Oncologic Drugs Advisory Committee thinks about it, so the agency has convened a meeting of the committee for a deep dive into the subject on April 12.
In July, Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd.) became the first amyloid-targeting drug to win traditional approval from the U.S. FDA, after getting accelerated approval in January based on the surrogate endpoint of plaque removal.
GSK plc is looking at a comeback for Blenrep (belantamab mafodotin) as an interim efficacy analysis brought the company good news. Almost exactly a year ago, phase III confirmatory study data for the already-approved multiple myeloma drug fell short of the U.S. FDA’s accelerated approval requirements, so the agency asked GSK to take the drug off the market for the indication.
From the start of the Nov. 16 Oncologic Drugs Advisory Committee meeting, the U.S. FDA made it clear that withdrawing Acrotech Biopharma Inc.’s peripheral T-cell lymphoma drugs, Folotyn (pralatrexate) and Beleodaq (belinostat), from the market until a long-overdue confirmatory trial is completed is not an option given the current treatment landscape.
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
In a show of bipartisan solidarity, members of the U.S. Senate Special Committee on Aging voiced their support Oct. 26 for a new regulatory pathway to quicken access to new drugs for rare diseases that have no approved treatments.
As it continues its crackdown on accelerated approval, the FDA continues to stress that successfully completing confirmatory trials should be the top priority for sponsors of drugs that enter the U.S. market via accelerated approval.
The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
