FDA Approvals, News & Updates

Kisqali Receives Expanded Indications for HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

October 2018, Vol 8, No 10 - FDA Approvals, News & Updates

On July 18, 2018, the FDA approved 2 new indications for ribociclib (Kisqali; Novartis) for use as (1) initial endocrine-based therapy, in combination with an aromatase inhibitor (AI), for the treatment of pre- and perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer; as well as (2) an initial endocrine-based therapy or after disease progression while receiving endocrine-based therapy, in combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. [ Read More ]

Opdivo plus Yervoy Approved for MSI-H or dMMR Colorectal Cancer

October 2018, Vol 8, No 10 - FDA Approvals, News & Updates

On July 10, 2018, the FDA accelerated the approval of the combination of nivolumab and ipilimumab (Opdivo and Yervoy; Bristol-Myers Squibb) for the treatment of patients aged ≥12 years with metastatic c­o­lorectal cancer (CRC) associated with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) that progressed after chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan. [ Read More ]

Braftovi plus Mektovi a New Combination for Unresectable or Metastatic Melanoma with BRAF Mutation

October 2018, Vol 8, No 10 - FDA Approvals, News & Updates

On June 27, 2018, the FDA approved the combination of encorafenib and binimetinib (Braftovi and Mektovi; Array BioPharma), 2 new kinase inhibitors, for the treatment of patients with unresectable or metastatic melanoma and the BRAF V600E or BRAF V600K mutation, as detected by the companion diagnostic THxID-BRAF Kit, which was approved on the same day. [ Read More ]

FDA Approves 2 New Biosimilars for Patients with Cancer

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On May 15, 2018, the FDA approved epoetin alfa-epbx (Retacrit; Pfizer) as the first biosimilar to epo­etin alfa (Epogen, Procrit; Amgen) for the treatment of anemia caused by chronic kidney disease, myelosuppressive chemotherapy, or the use of zidovudine in patients with HIV. The new biosimilar is also approved to reduce the need for allogeneic red blood cell transfusions in patients at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. [ Read More ]

Bevacizumab plus Chemotherapy Approved for Several Types of Ovarian Cancer

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On June 13, 2018, the FDA approved bevacizumab (Avastin; Genentech), in combination with carboplatin and paclitaxel, for the treatment of patients with resected, stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, to be followed with beva­cizumab monotherapy. Bevacizumab received orphan drug designation for this indication. [ Read More ]