Quarterly report also reveals 29% of approvals contained an immune checkpoint inhibitor and 43% were biomarker dependent
Atlanta, GA, September 27, 2021 — OncoHealth, the leading digital health company focused on the physical, mental and financial complexities of cancer care, has released its Q2 2021 quarterly report on the FDA’s newly approved drugs and indications and highlighted the continued rise in accelerated approvals as well as new concerns around their growth. OncoHealth’s quarterly report also reveals that 29% of approvals contained an immune checkpoint inhibitor and 43% were biomarker dependent. A copy of the report is available for download here.
Fifty percent (seven of 14) of new oncology indications received accelerated approvals in the quarter – up from 36% from the same quarter in 2020. Costs for the drugs receiving accelerated approvals in Q2 2021 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.
“As the FDA ramps up accelerated approvals, many of the new indications are being accepted with cautious optimism,” said Dr. Laura R. Bobolts, PharmD, BCOP, Senior Vice President, Pharmacy at OncoHealth. “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.”
In further analysis of FDA approval activity in Q2, the report notes that despite the focus on the COVID-19 pandemic over the past 18 months, the FDA was still busy approving oncology-related drug indications. The 14 approvals in the quarter brings the total in the first half of 2021 to 34 approved oncology indications. That’s in addition to the 66 oncology related approvals in 2020.
OncoHealth’s Q2 2021 report also notes that immune checkpoint inhibitors continue to expand in use, solidifying their place as standard of care in over 17 different tumor types and two tumor-agnostic indications—significantly improving the outcomes of cancer patients. 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.
Novel precision medicine approvals also continued to grow. In Q2 2021, 43% of approved oncology indications were biomarker dependent. Two of the seven new molecular entities (NMEs), or brand new to market oncology drugs approved in the second quarter of 2021 included new molecular targets in advanced/metastatic non-small cell lung cancer (NSCLC).
“Oncologists are increasingly turning to germline and somatic tumor testing to better inform treatment decisions,” said Dr. Bobolts. “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.”
“We work with providers and health plans to provide the latest oncology expertise to make sure patients receive treatment tailored to their unique cancer situation,” said Rick Dean, CEO of OncoHealth. “These recommendations are backed by evidence-based medicine demonstrating that the therapy is safe, effective, and offers the best value for patients and health plans. In our experience, this approach is the most successful way to control the rising cost of oncology drugs.”
Dr. Bobolts will be discussing the report findings and analysis during a webinar on September 30 at 2:00 p.m. ET. Click here to register.
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