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Half of the 14 oncology indications approved in the second quarter were accelerated approvals.
In the second quarter of 2021, the FDA approved 14 new oncology indications. Of these, half received accelerated approvals in the quarter, up from 36% from the same quarter in 2020, according to a report by OncoHealth (formerly Oncology Analytics). Costs for the drugs receiving accelerated approvals in the second quarter ranged from $166,404 to $485,336 annually. In the past two years, the FDA has granted 38 accelerated approvals in oncology drugs and indications.
The FDA accelerated approval pathway expedites authorization of new therapies that show clinical promise in addressing an unmet medical need, based on surrogate end points such as overall response rate and duration of response.
“As the FDA ramps up accelerated approvals, many of the new indications are being accepted with cautious optimism,” Laura R. Bobolts, Pharm.D., senior vice president, pharmacy at OncoHealth, said in a statement. “Delays in confirmatory trial results and lack of swift action by the FDA when subsequent studies fail has led some to question whether the FDA has allowed their evidence standards to become too permissive and inconsistent.”
The report also found that almost a third (29%) of new oncology indications during the second quarter of 2021 involved an immune checkpoint inhibitor, up from 25% during the same quarter of 2020. A consistent theme has emerged: roughly one in four FDA approvals contains an immune checkpoint inhibitor.
In April, the FDA’s Oncology Drugs Advisory Committee (ODAC) reviewed six immune checkpoint inhibitors that received accelerated approval. The members of ODAC voted to continue support of four of the six indications, despite their having failed to meet endpoints in confirmatory clinical trials.
The manufacturers for three of the six indications have initiated market withdrawal: Bristol Myers Squibb’s Opdivo (nivolumab) in previously treated hepatocellular carcinoma; Merck’s Keytruda (pembrolizumab) in third line or later PD-L1 positive metastatic gastric or gastroesophageal junction adenocarcinoma; and Genentech’s Tecentriq (atezolizumab) plus nabpaclitaxel in PD-L1 positive metastatic triple negative breast cancer. Two of these three indications recently withdrawn had been on the market since 2017.
The 14 approvals in the quarter brings the total in the first half of 2021 to 34 approved oncology indications. In the second quarter, 43% of approved oncology indications were biomarker dependent. Two of the seven new molecular entities included new molecular targets in advanced/metastatic nonsmall cell lung cancer (NSCLC).
“Oncologists are increasingly turning to germline and somatic tumor testing to better inform treatment decisions,” Bobolts said. “Providers are refining treatment approaches, leveraging molecular tumor boards, and customizing cancer care to an individual tumor's molecular fingerprint. Genetic testing use, especially with broad panel next generation sequencing, will only grow throughout 2021.”