Page 29 - Project Orbis News Today : Breaking News, Live Updates & Top Stories | Vimarsana

December 18, 2020 Today, the U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.  "Today’s approval of Tagrisso demonstrates how additional research on therapies approved in later stages of cancer can eventually improve treatment options for patients in earlier stages,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluatio...

LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination Demonstrated Statistically Significant Improvement in OS, PFS and ORR Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Systemic Therapy in Phase 3 Study First Overall Survival Analysis for LENVIMA Plus KEYTRUDA Combination in a Phase 3 Study in Advanced Endometrial Cancer TOKYO, Dec 17, 2020 - (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 pivotal Phase 3 Study 309/KEYNOTE-775 trial evaluat...

AbbVie: Health Canada Approves VENCLEXTA With Azacitidine Or Low Dose Cytarabine For Untreated AML OTTAWA (dpa-AFX) - Biopharmaceutical company AbbVie (ABBV) said Tuesday that Health Canada has approved VENCLEXTA (venetoclax) in combination with azacitidine or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. AML is an aggressive and difficult-to-treat blood cancer with a low survival rate. In Canada, the five-year survival rate for...

Health Canada’s approval of VENCLEXTA for newly diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from two Phase 3 trials – VIALE-A and VIALE-C 1 . The VIALE-A trial demonstrated a statistically significant increase in overall survival with VENCLEXTA in combination with azacitidine compared to azacitidine alone. 1 In the VIALE-C trial, clinical benefit was based on rate and … Health Canada’s approval of VENCLEXTA for newly diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from two Phase 3 trials – VIA...

Guidance on Project Orbis From: Print this page Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) to review and approve promising cancer treatments. It involves the regulatory authorities of: Australia (TGA) Brazil (ANVISA) It provides a framework for concurrent submission and review of oncology products among international partners. It aims to deliver faster patient access to innovative cancer treatments with potential benefits over existing therapies across the globe. The MHRA will participate fully in the scheme from 1 January 2021. While the FDA ser...