The FDA on March 13, 2017 approved KISQALI®, a cyclin-dependent kinase 4/6 inhibitor, in combination with an Aromatase Inhibitor, as initial endocrine-based therapy for the treatment of postmenopausal women with Hormone Receptor (HR)-positive, Human Epidermal Growth Factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. KISQALI®is a product of Novartis Pharmaceuticals Corp
Category: FDA Approvals
REVLIMID® (Lenalidomide)
The FDA on February 22, 2017 approved REVLIMID® as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. In 2006, REVLIMID®, an orally administered thalidomide analogue, received FDA approval for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy. In 2015, the indication was expanded for use in combination with dexamethasone for the treatment of patients with multiple myeloma, to include newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. REVLIMID® is also approved in Myelodysplastic syndromes and Mantle Cell Lymphoma. REVLIMID® is a marketed by Celgene Corp.
OPDIVO® (Nivolumab)
The FDA on February 2, 2017 granted accelerated approval to OPDIVO® for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. OPDIVO® is marketed by Bristol-Myers Squibb company.
RUBRACA® (Rucaparib)
The FDA on November 19, 2016 granted accelerated approval to RUBRACA® for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies. RUBRACA® is a product of Clovis Oncology, Inc.
DARZALEX® (Daratumumab)
The FDA on November 21, 2016 approved DARZALEX® in combination with REVLIMID® (Lenalidomide) and Dexamethasone, or VELCADE® (Bortezomib) and Dexamethasone, for the treatment of patients with multiple myeloma, who have received at least one prior therapy. DARZALEX® is a product of Janssen Biotech, Inc.
OPDIVO® (Nivolumab)
The FDA on November 10, 2016 approved OPDIVO® for the treatment of patients with recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN), with disease progression on or after a platinum-based therapy. OPDIVO® is marketed by Bristol-Myers Squibb company.
KEYTRUDA® (Pembrolizumab)
The FDA on October 24, 2016 approved KEYTRUDA® for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC), whose tumors express PD-L1, as determined by an FDA-approved test. This is the first FDA approval of a checkpoint inhibitor for first-line treatment of Lung cancer. This approval also expands the indication in second-line treatment of Lung cancer to include all patients with PD-L1-expressing NSCLC. KEYTRUDA® is a product of Merck & Co., Inc.
LARTRUVO® (Olaratumab)
The FDA on October 19, 2016 granted accelerated approval to LARTRUVO® for the treatment of patients with Soft Tissue Sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and with a histologic subtype for which an Anthracycline-containing regimen is appropriate. LARTRUVO® is a product of Eli Lilly and Company.
TECENTRIQ® (Atezolizumab)
The FDA on October 18, 2016 approved TECENTRIQ® for the treatment of patients with metastatic Non Small Cell Lung Cancer (NSCLC) whose disease progressed during or following Platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations, prior to receiving TECENTRIQ®. TECENTRIQ® is a product of Genentech, Inc.
TARCEVA® (Erlotinib)
The FDA on October 18, 2016 modified the indication for TARCEVA® for treatment of Non Small Cell Lung Cancer, to limit use to patients whose tumors have specific Epidermal Growth Factor Receptor (EGFR) mutations. TARCEVA® is a product of Astellas Pharm Global Development Inc.