Page 11 - Project Orbis News Today

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Osimertinib will be made available via the Cancer Drugs Fund (CDF) to patients in England with completely resected early-stage IB-IIIA EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).1

The drug is now also approved for adjuvant treatment following resection and platinum-based chemotherapy in early stage, non-small cell lung cancer with PD-L1 ≥ 1%.

(1) 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 Addre...

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 - 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...

Confirm - 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 - 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)...

FDA approves alternative component of chemotherapy regimen to treat acute lymphoblastic leukemia Today, the U.S. Food and Drug Administration approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. The only other FDA-approved drug for such patients w...

BMS drug Opdivo lands FDA approval for gastro cancers By Jenni Spinner The therapeutic has been approved as an adjuvant treatment for varieties of esophageal cancers in patients who have received neoadjuvant chemoradiotherapy. Bristol Myers Squibb (BMS) announced the US Food and Drug Administration (FDAP has approved Opdivo (nivolumab, injection for intravenous use) for adjuvant treatment of completely resected esophageal o...

Pivotal study demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in patients with previously-treated advanced cholangiocarcinoma (CCA)

/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung...