Oncology ·
FDA grants subcutaneous amivantamab accelerated approval in head and neck cancer; final 2027 Medicare fee schedule cuts conversion factor 2.31%

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The Food and Drug Administration (FDA) granted accelerated approval on Nov. 5 to subcutaneous amivantamab for previously treated recurrent or metastatic head and neck squamous cell carcinoma. The Centers for Medicare & Medicaid Services (CMS) issued the 2027 physician fee schedule final rule, cutting the main conversion factor 2.31%.
THE DETAILS
- FDA Nov 5, 2026The Food and Drug Administration (FDA) granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-based chemotherapy and immunotherapy; it is not indicated for HPV-associated oropharyngeal cancer. In 102 patients in the OrigAMI-4 trial, the overall response rate was 42% (95% CI 32% to 52%), and 56% of responders had a response lasting at least six months. The FDA said it is the first drug approval in 10 years for previously treated recurrent or metastatic disease, and it has required confirmatory studies.Sources: FDA, FDA Oncology Center of Excellence
- Payment Nov 4, 2026The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2027 Medicare physician fee schedule final rule, setting the conversion factor at $32.63 for clinicians outside qualifying alternative payment models, a decrease of $0.77 (2.31%), and at $32.95 for qualifying participants, a decrease of 1.83%. The American College of Radiology (ACR) said policy changes in the rule bring a 2% increase for radiation oncology, though actual impacts may be less because of the conversion factor decrease, according to AuntMinnie.Sources: CMS, AuntMinnie
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