FDA Approvals, News & Updates
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 More ›
On July 30, 2019, the FDA approved darolutamide (Nubeqa; Bayer) for the treatment of patients with nonmetastatic castration-resistant prostate cancer.
Read More ›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.
Read More ›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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
By Loretta Fala
Lung and bronchus cancer, the second most common form of cancer, accounts for 13.5% of all new cancer cases in the United States. In 2018 alone, lung cancer was newly diagnosed in 234,030 individuals and accounted for 154,050 deaths. In fact, lung cancer is the leading cause of cancer-related mortality in men and women, and is responsible for more than 25% of all cancer deaths. The 5-year survival rate for patients whose lung cancer has spread regionally (to regional lymph nodes) is 29.7%, but that survival rate is only 4.7% for patients with distant metastases. Read More ›
By Loretta Fala
Prostate cancer is the third most common type of cancer in the United States, after breast cancer and lung cancer. In 2018 alone, 164,690 individuals were diagnosed with prostate cancer, accounting for nearly 10% of all new cancer cases, and 29,430 deaths were attributed to the disease. Prostate cancer is most frequently diagnosed in men aged 65 to 74 years (median age, 66 years). More than 98% of patients with prostate cancer survive ≥5 years; however, the 5-year survival rate drops to 30% for patients with metastatic disease. Read More ›