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Six important FDA updates

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The FDA has announced several decisions related to hematology and oncology treatments in the past 2 weeks.

HemOnc Today presents six FDA actions that may be relevant to your practice.

• The FDA granted approval to pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with metastatic non–small cell lung cancer whose tumors express programmed death ligand-1 as determined by an FDA–approved test. Read more.
• Ortho Clinical Diagnostics received FDA clearance for Ortho Vision Max, a fully automated blood analyzer intended for use in high-volume transfusion medicine laboratories. Read more.
• Olaratumab (Lartruvo, Eli Lilly) injection received accelerated approval for use in combination with doxorubicin to treat adults with soft tissue sarcoma. Read more.
• Atezolizumab (Tecentriq, Genentech) was approved for the treatment of certain patients with metastatic NSCLC. Read more.
• The FDA modified the indication for erlotinib (Tarceva; Genentech, Astellas) for patients with previously treated NSCLC. Read more.
• The FDA awarded 21 clinical research grants for orphan drugs, encompassing more than $23 million during the course of the next 4 years, to develop products for patients with rare diseases. Read more.