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.
It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago.
While last week’s marathon Oncologic Drugs Advisory Committee meeting to consider accelerated approvals for cancer drugs that didn’t demonstrate effectiveness in confirmatory trials was a good step forward, oncologists need the FDA to do more to ensure drug labeling truly reflects the benefit of the product.
If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year.
In a virtual meeting fraught with technical difficulties, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7-2 April 27 that the accelerated approval for Tecentriq (atezolizumab) in combination with nab-paclitaxel as a treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults with PD-L1+ tumors should continue as additional trials are conducted or completed.
As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so.
Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals.
The 2020 World Conference on Lung Cancer, which was scheduled to take place in Singapore last August, is set to kick off virtually later this week. The postponement gave companies time to generate additional data as they battle to treat patients with their targeted therapies.
HONG KONG – Following FDA approval of its IND, Israel-based Kahr Medical Ltd. is set to start a phase I/II trial of lead product DSP-107, a second-generation CD47- and 41BB-targeting compound. The move puts Kahr among a number of companies working on drugs against checkpoint molecule CD47.