Opdivo Plus Yervoy Gets FDA OK for Melanoma

“Indications for the blockbuster cancer drug nivolumab (Opdivo) have expanded again, as the FDA has approved the anti-PD-1 antibody in combination with ipilimumab (Yervoy) for treatment of unresectable or metastatic melanoma.

“The indication includes both BRAF-wild type and BRAF-mutant melanoma. At the same time, the FDA expanded the indication for single-agent nivolumb to include patients with previously untreated BRAF-wild type melanoma.

“Granted by the FDA’s accelerated approval process, the indication is the seventh for nivolumab, both indications leave the door open for the FDA to request confirmatory data or clinical trials. The approvals increase the number of nivolumab indications to seven, including four in melanoma, all granted since late 2014.”


The Growing Arsenal of Immunotherapy Drugs for Melanoma


Large numbers of immune cells (T cells in particular) are frequently found within or adjacent to melanoma tumors, indicating that the tumors attract the attention—if not the action—of the immune system. True to its reputation as one of the most ‘immunogenic‘ cancers, melanoma now has more U.S. Food and Drug Administration (FDA)-approved immunotherapy (immune system-targeting) drugs than any other cancer type. As a consequence, metastatic melanoma is no longer the universally fatal disease it was even just 3 or 4 years ago. Continue reading…


FDA Approves Two New Indications for Pembrolizumab in Advanced Melanoma

“The FDA has expanded the approval for single-agent pembrolizumab (Keytruda) to include the frontline treatment of patients with advanced melanoma regardless of BRAF status, based on a substantial improvement in progression-free and overall survival compared with ipilimumab (Yervoy) in the phase III KEYNOTE-006 trial.

“In the study, which compared 2 pembrolizumab regimens with ipilimumab, the PD-1 inhibitor reduced the risk of disease progression by >40% and the risk of death by >30%.

“ ‘As recently as five years ago, there were few treatment options for patients suffering from advanced melanoma,’ Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories, the developer of the PD-1 inhibitor, said in a statement. ‘Today’s news is another exciting milestone for Keytruda and for patients with this disease.’ “


FDA Grants Genentech’s Alecensa® (Alectinib) Accelerated Approval for People with a Specific Type of Lung Cancer

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Alecensa® (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. In the pivotal studies, Alecensa shrank tumors in up to 44 percent of people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR] of 38 percent [95 percent CI 28-49] and 44 percent [95 percent CI 36-53]). In a subset of people with tumors that spread to the brain or other parts of the central nervous system (CNS), Alecensa shrank CNS tumors in about 60 percent of people (CNS ORR of 61 percent [95 percent CI 46-74]).”


FDA Grants Priority Review to Xalkori for New Indication in NSCLC

“The FDA granted priority review to a supplemental new drug application for crizotinib.

“Crizotinib (Xalkori, Pfizer) — a kinase inhibitor — already is approved for treatment of patients with metastatic ALK-positive non–small cell lung cancer.

“The supplemental application requests that the approval be expanded to allow crizotinib to be used for treatment of patients with metastatic ROS1-positive NSCLC. The FDA granted breakthrough therapy designation to crizotinib for this indication in April.

“ROS1 rearrangement occurs in an estimated 1% of NSCLC cases, according to a Pfizer-issued press release.”


FDA Approves Ablatherm HIFU Treatment for Prostate Cancer

“The FDA has fully approved the Ablatherm high-intensity focused ultrasound device for the nonsurgical and noninvasive treatment of localized prostate cancer, according to a press release from the device’s manufacturer.

“Ablatherm high-intensity focused ultrasound (EDAP TMS), or Ablatherm HIFU, is recommended for men with localized prostate cancer (stages T1-T2) who are not candidates for surgery, who prefer an alternative option or who failed radiotherapy treatment.

“The device targets the tumor via a computer-controlled rectal probe. Ultrasound waves are intended to destroy the prostate tissue while sparing surrounding organs. Data have indicated the device is effective for prostatic tissue ablation with a low occurrence of side effects, according to the press release.”


Lung Cancer Patients Gain Access to New Treatment for Fourth Time in Two Months

“The International Association for the Study of Lung Cancer (IASLC) is pleased to hear of another approval by the U.S. Food and Drug Administration (FDA) that helps in the fight against lung cancer—the fourth in two months. The FDA approved necitumumab (Portrazza) in combination with standard chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for their advanced disease.

“Necitumumab binds to the epidermal growth factor receptor (EGFR), a protein commonly found on squamous NSCLC tumors, and blocks EGFR from binding its ligands, thus preventing tumor growth. Necitumumab is the first monoclonal antibody type of EGFR inhibitor to be approved in lung cancer, whereas there are a number of tyrosine kinase type of EGFR inhibitors (TKI) already FDA approved and used in clinical practice. These TKIs include gefitinib, erlotinib, afatinib, and osimertinib.”


FDA Approves Portrazza to Treat Advanced Squamous Non-Small Cell Lung Cancer

“The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.

“Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer, is further divided into two main types named for the kinds of cells found in the cancer – squamous cell and non-squamous cell (which includes adenocarcinoma).”


Novartis Gets FDA Approval for Skin Cancer Drug Combination

“Nov 20 Novartis AG said on Friday it received the U.S. Food and Drug Administration’s regular approval for a drug combination to treat an aggressive form of skin cancer.

“The FDA approved Tafinlar and Mekinist for treatment of metastatic melanoma based on two years overall survival in patients, the company said.

“The combination was initially approved based on mid-stage data through the FDA’s accelerated approval program, but the approval was contingent on data from late-stage trial.”