FDA Approvals, News & Updates

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

October 2018, Vol 9, No 3 - 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 9, No 3 - 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 9, No 3 - 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 ]

Keytruda Receives 2 New Indications: Metastatic Cervical Cancer and Relapsed Mediastinal Large B-Cell Lymphoma

August 2018, Vol 9, No 2 | Payers’ Perspectives In Oncology: ASCO 2018 Highlights - FDA Approvals, News & Updates

On June 12, 2018, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) for patients with recurrent or metastatic cervical cancer that progressed during or after chemotherapy and whose tumors express PD-L1, as determined by an FDA-approved test. Concurrently, the [ Read More ]