The latest in cancer prevention, diagnosis & treatment.
Opdivo Approved for Advanced Melanoma
The PD-1 inhibitor Opdivo (nivolumab) was granted approval for patients with unresectable or metastatic melanoma following treatment with Yervoy (ipilimumab) or a BRAF inhibitor. The U.S. Food and Drug Administration made the decision three months ahead of its scheduled March 2015 review.
The phase 3 CheckMate-037 trial randomized patients with advanced melanoma to receive Opdivo with chemotherapy---dacarbazine or intravenous carboplatin plus paclitaxel. Opdivo produced an overall response rate of 32 percent compared with 11 percent in patients treated with chemotherapy. In a six-month analysis, 95 percent of responses were ongoing. Fewer serious side effects were reported with Opdivo than with chemotherapy. Opdivo continues to be explored in other cancer types.
Cyramza OK’d for Gastric and Lung Cancers
Cyramza (ramucirumab) is a targeted agent that inhibits a protein involved in angiogenesis, the process of developing blood vessel growth to a tumor. In early November, the FDA approved Cyramza with paclitaxel for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Seven months earlier, the FDA had approved the drug for patients with the same conditions, but as a single agent.
The phase 3 RAINBOW study of Cyramza and paclitaxel showed a 2.3-month improvement in survival with the combination, and an increase in progression-free survival from 2.9 months to 4.4 months. Because treatment options are limited in this hard-to-treat disease, the survival advantage seen in the Cyramza group was heartening. Neutropenia and high blood pressure were common side effects in the combination arm.
On Dec. 12, the agency also approved Cyramza for the treatment of non-small cell lung cancer (NSCLC). Cyramza was tested in combination with docetaxel for the treatment of metastatic NSCLC
that had progressed on platinum-based chemotherapy. The anti-angiogenic drug improved overall survival by 1.4 months and progression-free survival by 1.5 months. About a third of patients in the combination arm experienced moderate to severe neutropenia.
Two Drugs Given Green Light in Ovarian Cancer
The PARP inhibitor Lynparza (olaparib) was approved after a study found it effective in heavily pretreated women with metastatic ovarian cancer who had the BRCA gene mutation. Along with that accelerated approval, the FDA OK’d companion blood test BRACAnalysis CDx, which identifies the presence of BRCA mutations. The approval was based on a 34 percent objective response rate in patients who had received at least three lines of chemotherapy and participated in a phase 2 study. Side effects included nausea, vomiting and diarrhea. In mid-November, Avastin (bevacizumab) was approved in combination with chemotherapy for women with recurrent ovarian cancer that is resistant to regimens containing platinum, becoming the first new treatment for this patient group in more than 15 years. The approval was based on phase 3 study results that showed improved progression-free survival (PFS). Avastin, which blocks a signal that encourages blood vessel growth to the tumor, doubled PFS when compared with chemotherapy alone (6.8 months versus 3.4 months). Median overall survival was also extended by three months. Different regimens of chemotherapy were used during the trial, including Taxol (paclitaxel). A subset of women who received Avastin with Taxol had higher PFS and survival when compared with patients treated with the other chemotherapy combinations. Reported side effects included high blood pressure and hand-foot syndrome.
FDA Approves Blincyto for Acute Lymphoblastic Leukemia
Accelerated approval was granted to the immunotherapy Blincyto (blinatumomab), a bispecific antibody, as a treatment for patients who have B-precursor acute lymphoblastic leukemia (ALL) that has recurred or not responded to other therapies. In a phase 2 trial, nearly a third of patients who received Blincyto experienced a complete remission for a median 6.7 months. The Dec. 3 announcement was well ahead of the FDA’s deadline, which provided the treatment to patients much earlier than expected. The most common side effects were fever, headache and swelling in the limbs. Neurological side effects occurred in approximately half of patients.
Advisory Committee Recommends First Biosimilar for FDA Approval
In a unanimous vote, an advisory committee to the FDA recommended a biosimilar version of Neupogen (filgrastim) for approval. If given a green light, it would become the first biosimilar approved in the United States. Biosimilars are considered generic versions of expensive targeted therapies, like Neupogen. The supportive care drug stimulates production of infection-fighting neutrophils. A phase 3 trial that compared EP2006 and Neupogen head-to-head in patients with breast cancer who had been treated with chemotherapy showed similar safety and efficacy.