“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.”
“The approval was based on a substantial improvement in overall survival (OS) in a phase 3 study.
“The FDA has expanded the approval for single-agent Opdivo (nivolumab) to include the frontline treatment of patients with BRAF wild-type advanced melanoma, based on a substantial improvement in overall survival (OS) compared with the chemotherapy dacarbazine in a phase 3 study.
“In the data assessed by the FDA from the CheckMate-066 trial, the median OS with Opdivo was not reached versus 10.8 months for dacarbazine, representing a 58 percent reduction in the risk of death. Median progression-free survival (PFS) with Opdivo was 5.1 versus 2.2 months for dacarbazine.”
“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).”
“The FDA has approved a combination of vemurafenib (Zelboraf) and cobimetinib (Cotellic) to treat patients with metastatic or unresectable BRAF V600E/K mutation-positive melanoma. The approval was based on based on an extension in progression-free survival (PFS) in the phase III coBRIM study.
“In the data submitted to the FDA, the median PFS with the combination was 12.3 versus 7.2 months with vemurafenib plus placebo (HR, 0.58; 95% CI, 0.46-0.72). PFS was the primary endpoint of the study with secondary outcome measures including overall survival (OS), objective response rate (ORR), duration of response, and safety.”
“Bristol-Myers Squibb CompanyBMY, -0.27% today announced that the U.S. Food and Drug Administration (FDA) has approved Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection including total lymphadenectomy. This approval is based on clinical data from a pivotal Phase 3 trial, CA184-029 (EORTC 18071), which demonstrated Yervoy 10 mg/kg significantly improved recurrence-free survival (RFS) vs. placebo in this setting, with a 25 percent reduction in the risk of recurrence or death. The median RFS was 26 months (95% ci:19)(95% ci:39) for Yervoy vs. 17 months (95% ci:13)(95% ci:22) for placebo (hazard ratio [HR]=0.75; 95% CI: 0.64, 0.90; p<0.002). Yervoy is the first and only FDA-approved immune checkpoint inhibitor in the adjuvant treatment for fully resected Stage III melanoma (lymph node >1 mm).”
“The FDA has announced a de novo clearance for a minimally invasive high-intensity focused ultrasound (HIFU) prostate tissue ablation device called Sonablate 450. This clearance marks the first time HIFU technology will be used in the United States.
“ ‘It is anticipated that ablative urological surgeons in the US will quickly master and adapt this technology for their patients,’ said Herbert Lepor, MD, professor and Martin Spatz Chairman, Department of Urology, New York University School of Medicine, in a statement. ‘HIFU offers the opportunity for the precise delivery of ablative energy to the prostate. Thus, it can be adapted to whole gland or focal gland ablation.’
“Sonablate 450 is used on patients with low-to-high-risk prostate cancer with a PSA lower than 10 ng/mL who have progressed on external beam radiation therapy. The device utilizes a fully integrated probe with dual ablation transducer and focuses ultrasound energy at a targeted location in the prostate gland called the focal point, which is heated to nearly 195 degrees Fahrenheit (90 degrees Celsius). The tissue targeted at the focal point is destroyed, but tissue surrounding the targeted area remains unharmed.”
“Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. In a Phase 3 trial, CheckMate -057, Opdivodemonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy, with a 27% reduction in the risk of death (hazard ratio: 0.73 [95% CI: 0.60, 0.89; p=0.0015]), based on a prespecified interim analysis. The median OS was 12.2 months in the Opdivo arm (95% CI: 9.7, 15.0) and 9.4 months in the docetaxel arm (95% CI: 8.0, 10.7). This approval expands Opdivo’s indication for previously treated metastatic squamous NSCLC to include the non-squamous patient population. Squamous and non-squamous NSCLC together represent approximately 85% to 90% of lung cancer cases.”
“The FDA granted priority review to a new drug application for rociletinib.
“Rociletinib (Clovis Oncology) — a novel, oral, targeted covalent mutant-selective epidermal growth factor receptor inhibitor — is intended for patients with advanced EGFR-mutant, T790M-positive non–small cell lung cancer who already received EGFR-targeted therapy.
“The FDA is expected to make a decision about the agent’s status by March 30, 2016.”