Oncology Drug Approvals - Q2 2021 Report
Key Insights from OncoHealth's Q2 2021 Report
OncoHealth, the main advanced health association focused on the physical, internal, and financial complications of cancer care, has released its Q2 2021 report detailing the FDA's latest approved oncology drugs. This report highlights the increase in accelerated approvals as well as emerging concerns regarding their development.
Accelerated Approvals and Safety Designations
OncoHealth's report reveals that 29 of the approvals featured a safe designated spot asset, while 43 were biomarker inferior. Fifty (seven of 14) new oncology drugs received accelerated approvals in this quarter, an increase from 36 in the same quarter of 2020.
Cost Trends
The costs associated with the drugs receiving accelerated approvals in Q2 2021 ranged from $404 to $336 annually. Over the past two years, the FDA has granted 38 accelerated approvals in oncology.
FDA's Approval Trends
"As the FDA increases its accelerated approvals, a significant number of new drugs are being granted with cautious optimism," stated the Senior Vice President of Pharmacy at OncoHealth. Concerns remain regarding delays in confirming primary issues and the lack of prompt action by the FDA during prior investigations.
FDA Activity Amidst COVID-19
Despite the focus on the COVID-19 pandemic in recent months, the FDA has continued to approve oncology-related drugs. The 14 approvals in Q2 contribute to a total of 34 oncology drugs approved in the first half of 2021, in addition to the 66 oncology-related approvals in 2020.
Emerging Treatments and Biomarkers
OncoHealth's Q2 2021 report also notes that immune checkpoint inhibitors continue to grow in usage, establishing their place as the standard of care in over 17 distinct cancer types. Nearly a third (29) of new oncology drugs in the second quarter of 2021 involved an immune checkpoint asset, up from 25 in the same quarter of 2020.
Trends in Drug Approvals
A notable trend is that one in four FDA approvals now contains a safe designated spot asset. In Q2 2021, 43 of the approved oncology drugs were biomarker inferior. Two of the seven new molecular entities (NMEs) supported in the second quarter of 2021 introduced new molecular targets for advanced/metastatic non-small cell lung cancer (NSCLC).
Future Directions in Oncology
Oncologists are increasingly turning to germline and tumor testing to better inform treatment decisions.
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