Merck Igea Luca Dezzani

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

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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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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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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

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

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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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

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Lynparza meets primary endpoint in Phase III trial in BRCA-mutated metastatic breast cancer

17 February 2017 AstraZeneca has announced positive results from its Phase III OLYMPIAD trial comparing Lynparza (olaparib) tablets (300mg twice daily) to physician’s choice of a standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations. It was found that patients treated with Lynparza showed a clinically-meaningful and statistically-significant improvement … Continue reading Lynparza meets primary endpoint in Phase III trial in BRCA-mutated metastatic breast cancer

Cellectis Gains FDA Approval for Testing New Gene-Edited Cancer Treatment

Feb 7, 2017 Cellectis, the Paris-based biotech, has received an Investigational New Drug, or IND, approval from the U.S. Food and Drug Administration (FDA) for conducting phase I clinical trials with UCART123, the gene-edited product candidate of the biotech, in patients with acute myeloid leukemia, or AML, and blastic plasmacytoid dendritic cell neoplasm, or BPDCN. This is … Continue reading Cellectis Gains FDA Approval for Testing New Gene-Edited Cancer Treatment

AstraZeneca expands opportunities for 1st-line lung cancer Immuno-Oncology program

17 January 2017 AstraZeneca has provided an update on its Immuno-Oncology (IO) late-stage clinical development program in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the Phase III MYSTIC trial. The MYSTIC trial was initially designed to assess the benefit of durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combination therapy versus standard-of-care (SoC) … Continue reading AstraZeneca expands opportunities for 1st-line lung cancer Immuno-Oncology program