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Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma


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Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation
Study Results Demonstrated Statistically Significant Improvements in Overall Survival, Progression-Free Survival and Overall Response Rate, Helping to Address a Significant Unmet Need in Advanced Endometrial Carcinoma
TOKYO and KENILWORTH, N.J., July 23, 2021 - (JCN Newswire) - Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co. ....

United States , Gregory Lubiniecki , Vicky Makker , Oncology Clinical Research , Drug Administration , Oncology Business Group At Eisai , Eisai Co Ltd , Merck Co Inc , Research Laboratories , Memorial Sloan Kettering Cancer Center , Tyrosine Kinase Inhibitor Combination Approved , Patients With Advanced Endometrial Carcinoma That , Not Microsatellite Instability High , Mismatch Repair Deficient , Any Setting , Are Not Candidates , Curative Surgery , Overall Survival , Progression Free Survival , Overall Response Rate , Significant Unmet Need , Advanced Endometrial , United Statesa , Memorial Sloan Kettering Cancer , Vice President , Takashi Owa ,

U.S. FDA Grants Full Approval of REZUROCK(TM) (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)


U.S. FDA Grants Full Approval of REZUROCK(TM) (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)
ACCESSWIRE
17 Jul 2021, 04:31 GMT+10
- REZUROCK is approved for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy
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NEW YORK, NY / ACCESSWIRE / July 16, 2021
/ Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved REZUROCK
™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. The FDA granted Breakthrough Therapy designation and Priority Review for REZUROCK and reviewed the New Drug Application (NDA) under the Real-Time Oncology Review (RTOR) pilot program. The FDA approved this NDA six weeks ahead of the Presc ....

United States , Stephanie Lee , Corey Cutler , Harlanw Waksal , Ellen Cavaleri , Oncology Center , Drug Administration , Professor Of Medicine At Harvard Medical School , Exchange Commission , Adult Stem Cell Transplantation Program , Kadmon Holdings Inc , Program At Fred Hutchinson , University Of Washington School Medicine , Dana Farber Cancer Institute , Fred Hutchinson Cancer Research Center , Host Conference Call , Kadmon Holdings , Breakthrough Therapy , Priority Review , New Drug Application , Real Time Oncology Review , Prescription Drug User Fee Act , Associate Professor , Harvard Medical School , Medical Director , Dana Farber Cancer ,