FDA Approvals, News & Updates

FDA issues finalized guidelines for use of in vitro diagnostics in oncology drug trials and warnings on vaping; new findings report patients bear more costs when MBC treatment is not concordant with NCCN guidelines. Read Article ›

On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene) for the treatment of patients with intermediate-2 or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis. Read Article ›

On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review. Read Article ›

On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer) for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

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On August 15, 2019, the FDA granted accelerated approval to entrectinib (Rozlytrek; Genentech) for the treatment of patients aged ≥12 years with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed after treatment or have no satisfactory standard therapy.

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On June 10, 2019, the FDA accelerated the approval of polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody-drug conjugate, in combination with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan or a biosimilar; BR) for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received ≥2 previous therapies. Read Article ›

On June 27, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with lenalidomide (Revlimid; Celgene) and dexamethasone for the first-line treatment of patients with multiple myeloma (MM) who are ineligible for autologous stem-cell transplantation. This is the sixth indication for daratumumab in MM and the second for newly diagnosed patients. Read Article ›

On May 3, 2019, the FDA approved a new indication for ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab (Herceptin)-based treatment. The FDA granted this application priority review. Read Article ›

On May 24, 2019, the FDA approved Piqray (alpelisib; Novartis), an oral PIK3 inhibitor, in combination with endocrine therapy with fulvestrant (Faslodex), for the treatment of postmenopausal women, as well as men, with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer and PIK3CA mutation (as detected by an FDA-approved test) that progressed during or after an endocrine-based treatment regimen. The FDA used its priority review designation to consider the application of alpelisib. Read Article ›

Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to 15% of cases. Read Article ›

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