Darmstadt, Germany and New York (ots/PRNewswire) - - Not intended for US-, Canada- or UK-based media - ASCO Abstract # BAVENCIO® (avelumab): LBA1, 5061; Bintrafusp alfa (bifunctional fusion protein): 9558; Tepotinib (MET kinase inhibitor): 9556, 9575. - Late-breaking presentation of Phase III JAVELIN Bladder 100 data for BAVENCIO® showing overall survival benefit in ...
Not intended for US, Canada and UK-based media -- EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with BAVENCIO in combination with axitinib compared with sunitinib -- Combination regimen approved across all IMDC prognostic risk groups and ...
Not intended for US, Canada and UK-based media Darmstadt, Germany, and New York (ots/PRNewswire) - Merck and Pfizer Inc. (NYSE: PFE) today announced the presentation of multiple analyses from the JAVELIN clinical development program assessing BAVENCIO® (avelumab) alone or as part of combination regimens for the ...
Not intended for US, Canada and UK-based media - Opinion based on Phase III data showing combination lowered risk of disease progression or death by 31% and improved objective response rate compared with sunitinib1 - Decision by the European Commission anticipated in fourth quarter of 2019 Darmstadt, Germany and ...
Not intended for US, Canada and UK-based media Darmstadt, Germany and New York (ots/PRNewswire) - Merck and Pfizer Inc. (NYSE: PFE) today announced the discontinuation of the ongoing Phase III JAVELIN Ovarian PARP 100 study evaluating the efficacy and safety of avelumab in combination with chemotherapy followed by ...
Not intended for US, Canada and UK-based media Darmstadt, Germany and New York (ots/PRNewswire) - - JAVELIN Renal 101 shows significant improvement in progression-free survival with a hazard ratio of 0.69 in patients regardless of PD-L1 expression - US FDA has granted Priority Review to BAVENCIO plus INLYTA for ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US, Canada and UK-based media Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO® (avelumab) in ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US, Canada and UK-based media Merck and Pfizer Inc. (NYSE: PFE) today announced that data from a planned interim analysis of the Phase III JAVELIN Ovarian 100 study of avelumab* did not support the study's initial hypothesis, and therefore the ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US, Canada and UK-based media Merck and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxorubicin (PLD), a type of chemotherapy, compared ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US, Canada and UK-based media - First positive Phase III immunotherapy trial in combination with a tyrosine kinase inhibitor (TKI) in any tumor type - Results significant in both PDL1+ and all-comer populations - Alliance plans to pursue a ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for UK-based media Merck and Pfizer Inc. (NYSE: PFE) today announced results from the Phase III JAVELIN Lung 200 trial comparing avelumab* to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose ...
Darmstadt, Germany and New York (ots/PRNewswire) - - Second Breakthrough Therapy Designation for avelumab in hard-to-treat cancer - Renal cell carcinoma, the most common form of kidney cancer, has a poor prognosis in advanced stage[1],[2] - Javelin Renal clinical development program is ongoing, including Phase III ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for UK-based media - Pivotal Phase III Javelin trial investigating avelumab as third-line treatment for patients with unresectable, recurrent or metastatic gastric cancer did not meet its pre-specified primary endpoint of superior overall survival ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US, Canadian and UK-based media - First-ever treatment indicated for curatively unresectable Merkel cell carcinoma (MCC) and first anti-PD-L1 to be available in Japan - Japanese Ministry of Health, Labour and Welfare (MHLW) decision based on Javelin Merkel 200 study, the largest registrational trial for an immunotherapy in MCC - First Asian approval for ...
Darmstadt, Germany, and New York, Usa (ots/PRNewswire) - Not intended for US, Canadian and UK-based media - First approved immunotherapy for rare and aggressive skin cancer in the European Union, with initial launches planned in Germany and the UK - Builds on Bavencio's previous accelerated approvals in the US and recent approval in Switzerland - Approval is based on ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US, Canadian and UK-based media - If approved, avelumab could be the first immunotherapy treatment indicated for this rare and aggressive skin cancer in the EU - Decision by the EC is expected in the third quarter of 2017 Merck and Pfizer Inc. (NYSE: PFE) today announced that the Committee for ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US, Canada and UK-based media - A total of 13 abstracts across seven hard-to-treat cancers highlight the progress of avelumab as a monotherapy and potential novel combination treatment option - New data in metastatic Merkel cell carcinoma and ...
Darmstadt, Germany, and New York (ots/PRNewswire) - - Second approval for BAVENCIO in less than two months - Advanced urothelial carcinoma is an aggressive disease with a high rate of recurrence Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection for the treatment of patients with ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for UK-based media - Only FDA-approved treatment for metastatic Merkel cell carcinoma, a rare and aggressive skin cancer - First indication for BAVENCIO, a human anti-PD-L1 antibody Merck and Pfizer Inc. (NYSE: PFE) today announced that the US Food and ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for US and UK-based media - Second Biologics License Application accepted by the FDA for avelumab - Prognosis for urothelial carcinoma is currently poor, particularly when the disease has metastasized Merck and Pfizer Inc. today announced that the US ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for UK-based media - If approved by the FDA, avelumab, an investigational immunotherapy, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma (MCC) - Avelumab has previously received FDA Breakthrough Therapy and Fast ...
Darmstadt, Germany and New York (ots/PRNewswire) - Not intended for UK-based media - If approved, avelumab, an investigational anti-PD-L1 IgG1, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma - The Marketing Authorization Application is based on Phase II data from the ...
Darmstadt, Germany And New York (ots/PRNewswire) - Not intended for UK-based media - First of several registration trials expected to start in 2015 for the alliance between Merck and Pfizer - Initiation and first patient treated in Phase III clinical study recruiting across approximately 290 sites in more than 30 ...
Darmstadt, Germany And New York (ots/PRNewswire) - Not intended for UK-based media - In the second and third quarters of 2015, Merck and Pfizer will begin co-promoting XALKORI in the United States, Canada, Japan and five European Union countries (France, Germany, Italy, Spain and the United Kingdom) - In the United States and Canada, XALKORI will be co-promoted by EMD ...