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.
Given the advances being made in cancer treatments, it’s time to move beyond the maximum tolerated dose (MTD) to dose-optimization trials for targeted therapies, the U.S. FDA said in a new draft guidance.
In the wake of ongoing criticism over the U.S. FDA’s 2021 accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, the percentage of novel drugs receiving accelerated approval last year was the lowest it’s been since 2018.
Spectrum Pharmaceuticals Inc. president and CEO Tom Riga said the company would "immediately deprioritize" its poziotinib program after the U.S. FDA issued a complete response letter (CRL) suggesting the company would have to generate new clinical data prior to potential approval.
U.S. lawmakers concerned about unconfirmed clinical benefit of drugs with accelerated approval got more fodder for their arguments in a new report from the Department of Health and Human Services Office of Inspector General (OIG). According to that report, which was released Sept. 29, Medicare and Medicaid have spent more than $18 billion over the past few years covering 18 drugs granted accelerated approval that haven’t completed their confirmatory trials even though the trial completion dates have passed.
The fate of three cancer drugs, and possibly the future financial health of their sponsors, could be on the line Sept. 22 and 23 as the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) takes a hard look at the safety-efficacy data for Spectrum Pharmaceuticals Inc.’s Pozenveo, Oncopeptides AB’s Pepaxto and Secura Bio Inc.’s Copiktra. First up in the triple-header is Pozenveo (poziotinib), which is seeking accelerated approval as a second-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer harboring HER2 exon 20 insertion mutations confirmed by an FDA-approved test.
Spectrum Pharmaceuticals Inc. celebrated a long-awaited win with the U.S. FDA’s approval late Sept. 9 of novel G-CSF drug eflapegrastim, cleared for use in chemotherapy-induced neutropenia nearly four years after the company first filed for regulatory approval. Despite moves this year to reduce its cash burn, Spectrum has ready to go a commercial team expected to sell eflapegrastim as well as cancer drug poziotinib, which is under FDA review with a PDUFA date of Nov. 24, 2022.
Continuing its evaluation of cancer drugs already on the U.S. market, the FDA will convene its Oncologic Drugs Advisory Committee (ODAC) Sept. 22 and 23 to consider two more approved drugs – Oncopeptides AB’s Pepaxto (melphalan flufenamide) and Secura Bio Inc.’s Copiktra (duvelisib).
Manufacturing deficiencies were cited in the FDA’s complete response letter (CRL) for Spectrum Pharmaceuticals Inc.’s Rolontis (eflapegrastim), a decision that will further delay to market in the U.S. what could be the *first novel G-CSF drug in more than 15 years to treat chemotherapy-induced neutropenia.
Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected.
