Top Pharma News of the Week

FDA Accepts Supplemental Biologics License Application for Prolia® (Denosumab) in Glucocorticoid-Induced Osteoporosis


October 9, 2017

Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on July 28, 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018.

Lilly Reports Topline Results from Phase 3 JUNIPER Trial Evaluating Verzenio™ (abemaciclib) in KRAS-Mutated, Advanced Non-Small Cell Lung Cancer


October 10, 2017

Eli Lilly and Company has announced that its Phase 3 JUNIPER study evaluating Verzenio™ (abemaciclib), a cyclin-dependent kinase (CDK)4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non-small lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS). However, an analysis of the secondary study endpoints of both progression-free survival (PFS) and overall response rate (ORR) showed evidence of monotherapy activity in the abemaciclib arm. In addition, the control arm showed a higher overall survival rate than expected based on historical data in this setting.

AbbVie and Turnstone Biologics Announce Global Collaboration on Viral Immunotherapies in Oncology


October 10, 2017

AbbVie and Turnstone Biologics, a clinical-stage immuno-oncology company, have announced a research option and license agreement whereby AbbVie obtained an exclusive option to license up to three of Turnstone’s next-generation oncolytic viral immunotherapies. Under the terms of the agreement, AbbVie has an option to obtain all global development and commercialization rights to Turnstone Biologics’ Ad-MG1-MAGEA3 therapy, which is in two Phase 1/2 clinical trials for multiple solid tumor indications both alone and in combination with an approved anti-PD-1 checkpoint inhibitor, as well as up to two research-stage candidates to be developed by Turnstone as part of the collaboration. Each of the three therapies leverages Turnstone’s first-in-class platform based on an engineered Maraba virus. In the event AbbVie exercises one or more of its options, AbbVie expects to pursue this immunotherapeutic technology across several types of solid tumors.

Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer


October 11, 2017

Janssen Biotech, Inc. has announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.

U.S. FDA Approves Lyrica® Cr (Pregabalin) Extended-Release Tablets CV


October 12, 2017

Pfizer Inc. has announced that the United States Food and Drug Administration (FDA) has approved LYRICA® CR (pregabalin) extended-release tablets CV as once-daily therapy for the management of neuropathic pain associated with diabetic peripheral neuropathy (pDPN) and the management of postherpetic neuralgia (PHN). LYRICA CR did not receive approval for the management of fibromyalgia.

CHMP Issues a Positive Opinion on Janssen’s ZYTIGA® to Include Earlier Stage Prostate Cancer Patients


October 13, 2017

Janssen-Cilag International NV has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorisation for ZYTIGA® (abiraterone acetate) plus prednisone / prednisolone to include an earlier stage of prostate cancer than its current indications. If approved by the European Commission, abiraterone acetate plus prednisone / prednisolone in combination with androgen deprivation therapy (ADT) can be used for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).

CHMP recommends EU approval of Roche’s Alecensa (alectinib) as a first-line treatment for people with ALK-positive NSCLC


October 13, 2017

Roche has announced that the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Alecensa® (alectinib) as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). It has also simultaneously recommended the conversion of the current conditional marketing authorisation for Alecensa in crizotinib failure (second-line) to a full marketing authorisation.

Pfizer Presents Full Results from Phase 2 Study of Next-Generation Investigational Alk-Inhibitor Lorlatinib In Alk-Positive and Ros1-Positive Advanced Non-Small Cell Lung Cancer


October 16, 2017

Pfizer Inc. has announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated. Further, side effects were generally manageable and primarily mild to moderate in severity.

Rapidly Progressing Advanced Non-Small Cell Lung Cancer Patients Shown to Benefit in New CYRAMZA® (ramucirumab) Phase 3 Subgroup Analysis


October 16, 2017

New subgroup analysis from Eli Lilly and Company’s Phase 3 REVEL trial of CYRAMZA® (ramucirumab) in advanced non-small cell lung cancer (NSCLC) was presented today at the 18thWorld Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan. Specifically, these new data are an exploratory, post-hoc analysis focused on patients whose cancer rapidly progressed on first-line therapy. Time-to-progression (TTP) is defined as the time from start of first-line therapy until progressive disease – when the person’s cancer grows, spreads or gets worse. In this analysis, aggressive disease was defined based on rapid TTP on first-line therapy.

Top Pharma News of the Week last edit: 2017-10-16T18:23:24+00:00 da Luca

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