OncoHealth's Analysis of the FDA's H2 2021 Drug Approval Activity Shows Largest Number of Oncology Accelerated Approval Withdrawals in 11 Years
Report also reveals a 35% increase in cancer indication approvals, and a 5x rise in pre- and postoperative approvals in the curative-intent setting
ATLANTA, Dec. 14, 2021 /PRNewswire/ -- OncoHealth, the leading digital health company focused on the physical, mental and financial complexities of cancer care, has released its quarterly report on the FDA's newly approved oncology drug indications. Highlights include new approvals in the curative-intent setting and an unprecedented number of withdrawals of advanced cancer therapies previously granted accelerated approval. A copy of the report is available for download here.
The rise in adjuvant (postoperative) and/or neoadjuvant (preoperative) approvals in curative-intent settings was significant, comprising 15% of newly approved oncology indications in the second half of 2021 compared to only 3% in the second half of 2020. Most of these approvals involved immune checkpoint inhibitors.
Also, this year, nine oncology FDA indications were withdrawn following failure to confirm benefit after receiving accelerated approval. Only 17 total oncology indications have been withdrawn from the market in the past 11 years under the accelerated approval program with 53% of them occurring this year. That makes 2021 the FDA's most active year for program withdrawals since 2011 when Avastin's breast cancer indication was the first to be withdrawn. There was a 200% rise in oncology withdrawals in the second half of this year compared to the first half.
"Many have questioned whether the FDA standards for accelerated approvals have slipped, especially after approval of the controversial Alzheimer's drug, Aduhelm," said Dr. Laura R. Bobolts, PharmD, BCOP, Senior Vice President, Pharmacy, OncoHealth. "I believe this wave of withdrawals points to the added pressure placed on the FDA to take action on drugs that have not confirmed clinical benefit for the patients relying on them."
The OncoHealth report also notes that the FDA approved over 35% more cancer indications in the second half of 2021 compared to the same period in 2020. Tecartus became the first CAR T-cell therapy for adults with acute lymphoblastic leukemia, approved in October.
"The pipeline of new targeted agents in oncology is as robust as ever," said Dr. Bobolts. "But novel therapies come with major costs. For example, Tecartus has a list price of $373,000 and negotiated average commercial costs published as high as $819,000 for one dose. This is not sustainable. Roughly one-third of the cancer treatment regimens approved by the FDA in the second half of 2021 exceed $150,000 in drug costs alone for six months of treatment. That's nearly double the cost of therapy with an immune checkpoint inhibitor."
Dr. Bobolts will be discussing the report findings and analysis during a webinar on December 16 at 2:00 p.m. ET. Click here to register.
About OncoHealth
OncoHealth is a leading digital health company dedicated to helping health plans, employers, providers, patients, and life science researchers navigate the physical, mental, and financial complexities of cancer through technology-enabled services and real-world data analytics. Supporting more than 7 million people in the US and Puerto Rico, OncoHealth offers digital solutions for treatment review, real-world evidence, and virtual care across all cancer types. For more information, visit www.oncohealth.us.
SOURCE OncoHealth
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