The Food and Drug Administration (FDA) has granted accelerated approval to biopharmaceutical company Verastem Oncology’s combination therapy for adults who have received prior treatment for a rare type of ovarian cancer, the regulator announced on Thursday.
The FDA approved Avmapki Fakzynja co-pack (avutometinib capsules; defactinib tablets) for patients with recurrent Kirsten rat sarcoma viral oncogene homolog (KRAS) mutated low-grade serous ovarian cancer (LGSOC) who received prior systemic therapy.
It marks the first and only approval for a drug to treat adults with this form of cancer, the Massachusetts-based drug maker said.
The new therapy will be available in the United States in one week at a list price of $48,500 for a 28-day prescription….