The FDA in September 2017, approved VERZENIO® (Abemaciclib) in combination with FASLODEX® (Fulvestrant) for women with Hormone Receptor positive (HR-positive), HER2-negative, advanced or metastatic breast cancer, with disease progression following endocrine therapy. In addition, VERZENIO® was approved as monotherapy for women and men with HR-positive, HER2-negative advanced or metastatic breast cancer, with disease progression following endocrine therapy and prior chemotherapy, in the metastatic setting. The approval of VERZENIO® in combination with FASLODEX® was based on MONARCH 2 study which showed that a combination of VERZENIO® plus FASLODEX® significantly improved Progression Free Survival and Objective Response Rates, with a tolerable safety profile, in patients with Hormone Receptor-positive and HER 2-negative metastatic breast cancer, who had progressed while receiving endocrine therapy.
Category: FDA Approvals
FDA Approves ALIQOPA®, a PI3K Inhibitor, for Follicular Lymphoma
The FDA in September 2017, granted accelerated approval to ALIQOPA® (Copanlisib) for the treatment of adult patients with relapsed Follicular Lymphoma, who have received at least two prior systemic therapies. Follicular Lymphoma is the most indolent form and second most common form of all Non Hodgkin Lymphomas and approximately 30% of the patients will relapse in 3 years following initial treatment. ALIQOPA® is a pan-class 1, PI3K inhibitor with inhibitory activity predominantly against PI3K-α and PI3K-δ Isoforms expressed in malignant B cells. ALIQOPA® has significant activity in patients with relapsed/refractory indolent B-cell lymphoma, and the safety was manageable, compared with other PI3K inhibitors.
VERZENIO® (Abemaciclib)
The FDA on September 28, 2017 approved VERZENIO® in combination with Fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer, with disease progression following endocrine therapy. In addition, VERZENIO® was approved as monotherapy, for women and men with HR-positive, HER2-negative advanced or metastatic breast cancer, with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. VERZENIO® is a product of Eli Lilly and Company.
OPDIVO® (Nivolumab)
The FDA on September 22, 2017 granted accelerated approval to OPDIVO®, for the treatment of HepatoCellular Carcinoma (HCC), in patients who have been previously treated with Sorafenib. OPDIVO® is a product of Bristol-Myers Squibb Co.
KEYTRUDA® (Pembrolizumab)
The FDA on September 22, 2017 granted accelerated approval to KEYTRUDA® for patients with recurrent locally advanced or metastatic, Gastric or GastroEsophageal Junction adenocarcinoma, whose tumors express PD-L1, as determined by an FDA-approved test. KEYTRUDA® is a product of Merck & Co., Inc.
ALIQOPA® (Copanlisib)
The FDA on September 14, 2017 granted accelerated approval to ALIQOPA®, for the treatment of adult patients with relapsed Follicular Lymphoma, who have received at least two prior systemic therapies. ALIQOPA® is a product of Bayer HealthCare Pharmaceuticals Inc.
JEVTANA® (Cabazitaxel)
The FDA on September 14, 2017 approved a lower dose of JEVTANA® (20 mg/m2 every 3 weeks) in combination with Prednisone for the treatment of patients with metastatic Castration-Resistant Prostate Cancer, previously treated with a Docetaxel-containing treatment regimen. JEVTANA® (25 mg/m2 every 3 weeks) was approved for this indication in 2010. JEVTANA® is a product of Sanofi-Aventis.
BESPONSA® (Inotuzumab ozogamicin)
The FDA on August 17, 2017 approved BESPONSA® for the treatment of adults with relapsed or refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL). BESPONSA® is a product of Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.
LYNPARZA® (Olaparib)
The FDA on August 17, 2017 granted regular approval to LYNPARZA® tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. LYNPARZA® is a product of AstraZeneca.
MYLOTARG® (Gemtuzumab ozogamicin)
The FDA on September 1, 2017 approved MYLOTARG® for the treatment of newly-diagnosed CD33-positive Acute Myeloid Leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older. MYLOTARG® may be used in combination with Daunorubicin and Cytarabine for adults with newly diagnosed AML, or as a stand-alone treatment for certain adult and pediatric patients. MYLOTARG® is a product of Pfizer Inc.