FDA approvals – Oct 2020
On October 4 more indications/medications/tests were approved by FDA
- Next-generation sequencing (NGS)-based FoundationOne CDx test as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase (NTRK) genes, NTRK1, NTRK2, and NTRK3, in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with larotrectinib.
- Venetoclax in combination for untreated acute myeloid leukemia.
- Pembrolizumab for the following indications:
- adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and
- pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
4. Nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.
Check August & September FDA approvals.
