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Luca Dezzani News, Regulatory and Guidelines

EU approves Novartis drug combination Tafinlar + Mekinist for BRAF V600-positive advanced non-small cell lung cancer (NSCLC)

APR 03, 2017 Novartis has announced the European Commission has approved Tafinlar®(dabrafenib) in combination with Mekinist® (trametinib) for treating patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). This approval marks the first targeted treatment approved for the patient population, who previously had few treatment options, in all 28 member states of the … Continue reading EU approves Novartis drug combination Tafinlar + Mekinist for BRAF V600-positive advanced non-small cell lung cancer (NSCLC)

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Luca Dezzani Business, News

Roche announces the launch of cobas HPV on the cobas 6800/8800 Systems for cervical cancer screening in markets

28 March 2017 Roche has announced the CE-IVD launch of cobas® HPV for use on the cobas® 6800/8800 Systems for cervical cancer screening. Human Papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA assay adds to the growing CE-IVD menu on the cobas 6800/8800 Systems, … Continue reading Roche announces the launch of cobas HPV on the cobas 6800/8800 Systems for cervical cancer screening in markets

Luca Dezzani News

FDA Approves the checkpoint contender avelumab from Merck KGaA and Pfizer

  March 23, 2017 The biopharma partners Merck KGaA and Pfizer came away with their first FDA approval of the checkpoint inhibitor avelumab. This made it the fourth drug in this category to make it to the market. The FDA approves this for Merkel cell carcinoma under an accelerated approval process. The drug is currently in … Continue reading FDA Approves the checkpoint contender avelumab from Merck KGaA and Pfizer

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Luca Dezzani News

FDA Approved Keytruda of Merck for Hodgkin lymphoma

March 14, 2017 Merck has received another FDA approval for Keytruda, and this time for classical Hodgkin lymphoma, marking the PD-1 blocker’s first green-light for use in liquid tumors. Regulators handed out the approval for patients who had already failed at least three therapies. The approval was a first for Merck, but it comes 9 months … Continue reading FDA Approved Keytruda of Merck for Hodgkin lymphoma

Luca Dezzani News, Regulatory and Guidelines

FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

March 6, 2017 The FDA has given Seattle Genetics the green light to continue the trials for its armed antibody dubbed SGN-CD33A (vadastuximab talirine) used for the treatment of acute myeloid leukemia. The biotech says it is implementing additional risk mitigation measures in all vadastuximab talirine studies, including “revised eligibility criteria and stopping rules for veno-occlusive disease.” … Continue reading FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

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Luca Dezzani News, Regulatory and Guidelines

Novartis gets FDA Approval for LEE011 for frontline use against breast cancer

March 13, 2017 Novartis has gained the FDA approval for LEE011, its CDK 4/6 drug now approved as a frontline therapy for postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with any aromatase inhibitor. Also known as ribociclib, the drug hits the market as Kisqali with … Continue reading Novartis gets FDA Approval for LEE011 for frontline use against breast cancer

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Luca Dezzani News, Research Results

Perjeta regimen of Roche helped people with an aggressive type of early breast cancer live longer, Phase III APHINITY study shows

March 2, 2017 Roche, Breast European Adjuvant Study Team (BrEAST), the Breast International Group (BIG) and Frontier Science Foundation (FS) have announced positive results from the phase III APHINITY study, which met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) … Continue reading Perjeta regimen of Roche helped people with an aggressive type of early breast cancer live longer, Phase III APHINITY study shows

Luca Dezzani News, Regulatory and Guidelines

FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma

February 28, 2017 EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, and Pfizer Inc. have announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for avelumab for Priority Review as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on … Continue reading FDA Accepts the Biologics License Application for Avelumab for the Treatment of Metastatic Urothelial Carcinoma

Luca Dezzani Business, News

Incyte turns to Penn for a collaboration on next-gen cancer combos

February 23, 2017 Incyte Corporation has signed off on a multi-year deal for collaborating with scientists at the University of Pennsylvania on its next-gen combos and cancer therapies. The Abramson Cancer Center of the university will take a lead role in looking at patient selection and combination opportunities as Incyte advances its plans to develop … Continue reading Incyte turns to Penn for a collaboration on next-gen cancer combos

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Luca Dezzani News, Regulatory and Guidelines

Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer

21 February 2017 Roche has announced that the European Commission has granted a conditional marketing authorisation for Alecensa® (alectinib) as monotherapy for treating adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Within one year of treatment, most people with ALK-positive NSCLC develop resistance to the current … Continue reading Roche receives EU approval of Alecensa (alectinib) for people with previously treated ALK-positive non-small cell lung cancer