FDA Grants Fast Track Designation to Reolysin for Metastatic Breast Cancer

Excerpt:

“The FDA granted fast track designation to pelareorep for the treatment of metastatic breast cancer, according to the drug’s manufacturer.

“Pelareorep (Reolysin, Oncolytics Biotech) is an immuno-oncology viral-agent designed to induce selective tumor lysis, and promote an inflamed tumor phenotype through innate and adaptive immune responses, according to a company-issued press release.

“An open-label, randomized phase 2 study evaluated the addition of IV pelareorep to paclitaxel for patients with advanced or metastatic breast cancer.”

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FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer

Excerpt:

“On Friday evening, Takeda Pharmaceuticals announced the FDA has approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

“Brigatinib is a kinase inhibitor that can be taken orally. The recommended dose is 90 mg orally once daily for the first 7 days. If 90 mg is tolerated during the first 7 days, patient should increase the dose to 180 mg orally once daily. The pill can be taken with or without food.”

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FDA Issues Complete Response Letter for Lutathera in Neuroendocrine Tumors

Excerpt:

“The FDA has issued a complete response letter (CRL) to Advanced Accelerator Applications informing the company that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.

“The CRL, which follows a discipline review letter (DRL) issued in November, requests new subgroup data, a safety update, and that revisions be made to the previously submitted data. The letter did not request the initiation of additional studies of Lutathera.”

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Roswell Park Cancer Institute Launches Trial to Test Cuban Lung Cancer Vaccine

Excerpt:

“Roswell Park Cancer Institute launched a clinical trial that will assess CIMAvax-EGF, a novel Cuban-developed immunotherapy for lung cancer.

“This is the first time an American center received FDA authorization to sponsor a clinical trial offering a Cuban-made therapy to U.S. patients. Researchers are working to accelerate the process of this and other innovative therapies to patients worldwide through a historic new business venture with the Cuban research institute.”

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Advanced Accelerator Applications Reports 15.4% Sales Growth in the Third Quarter of 2016 and Feedback from the FDA for Lutathera®, an Investigational Treatment for Neuroendocrine Tumors

Excerpt:

“Advanced Accelerator Applications S.A. …an international specialist in Molecular Nuclear Medicine (MNM), today announced its financial results for the third quarter of 2016 and that the U.S. Food and Drug Administration (FDA) issued feedback on its New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.”

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FDA Gives Ribociclib Priority Review for Frontline HR+/HER2- Breast Cancer

Excerpt:

“The FDA has granted priority review designation to a new drug application (NDA) for ribociclib (LEE011) for use in combination with letrozole as a frontline therapy for patients with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

“The NDA for the CDK 4/6 inhibitor is primarily based on findings from the phase III MONALEESA-2 trial, in which combining ribociclib with letrozole reduced the risk of progression or death by 44% compared with letrozole alone in the first-line setting for HR+/HER2- advanced breast cancer (HR, 0.556; 95% CI, 0.43-0.72; P = .00000329). Under the priority designation, the NDA will be reviewed within 6 months, compared with the standard 10-month review.”

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FDA Approves Atezolizumab for Lung Cancer

Excerpt:

“The FDA has approved atezolizumab (Tecentriq) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) who have progressed after a platinum-containing regimen and an FDA-approved targeted therapy for those patients harboring EGFR or ALK abnormalities.

“The approval is based on multiple clinical trials, the largest being the phase III OAK trial, which was presented at the 2016 ESMO Congress. In the study, atezolizumab reduced the risk of death by 26% compared with docetaxel in patients with advanced NSCLC following the failure of platinum-based chemotherapy. The median overall survival (OS) was improved by 4.2 months with the PD-L1 inhibitor versus chemotherapy. The survival benefit with atezolizumab was observed regardless of PD-L1 status or histology.”

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FDA Grants Breakthrough Therapy Designation for Genentech’s Alecensa® (Alectinib) for First-Line Treatment of People with ALK-Positive NSCLC

Excerpt:

“Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it has received a second Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its anaplastic lymphoma kinase (ALK) inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.”

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FDA Accepts Neratinib NDA for HER2-Positive Breast Cancer

Excerpt:

“The FDA has accepted a new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin), according to a statement from the developer of the TKI, Puma Biotechnology.

“The application included findings from the phase III ExteNET study, in which neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, according to findings published in Lancet Oncology. The FDA completes a standard review within 12 months from the time of submission, which was completed for neratinib on July 21, 2016.”

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