Along with the premarket approval of Siemens' 3D breast-imaging technology, the FDA approved seven oncology and hematology drugs in September.
Here are seven oncology and hematology drugs approved by the FDA in September:
- Selpercatinib for patients aged 2 years and older with advanced or metastatic medullary thyroid cancer with a RET mutation.
- Osimertinib for adult patients with locally advanced, unresectable (stage 3) non-small cell lung cancer with the following conditions:
- Disease has not progressed from platinum-based chemoradiation therapy
- Tumors have EGFR exon 19 deletions or exon 21 L858R mutations
- Isatuximab-irfc, with bortezomib, lenalidomide and dexamethasone, for adults newly diagnosed with multiple myeloma and ineligible for autologous stem cell transplant
- Amivantamab-vmjw, with carboplatin and pemetrexed, for adult patients with locally advanced or metastatic non-small cell lung cancer with the following conditions:
- Epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations
- Disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor
- Embrolizumab, with pemetrexed and platinum chemotherapy, as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma
- Ribociclib, with an aromatase inhibitor, for adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative stage 2 and 3 early breast cancer at high risk of recurrence.
- The FDA also approved a ribociclib and letrozole co-pack for the same indication
- The FDA also approved a ribociclib and letrozole co-pack for the same indication
- Atezolizumab and hyaluronidase-tqjs for subcutaneous injection, for all adult indications, as the intravenous formulation of atezolizumab including non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma and alveolar soft part sarcoma.