(IN BRIEF) AstraZeneca’s Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval is based on … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged acalabrutinib, AstraZeneca, autologous hematopoietic stem cell transplantation, bendamustine, blood cancers, Bruton’s tyrosine kinase, BTK inhibitor, Calquence, chemoimmunotherapy, COVID-19, Dave Fredrickson, ECHO Phase III trial, FDA, global regulatory review, international markets, Lymphoma Research Foundation, mantle cell lymphoma, MCL, Meghan Gutierrez, Michael Wang, oncology, PFS, progression-free survival, Project Orbis, regulatory submission, rituximab, safety profile, U.S. approval
(IN BRIEF) Sarclisa, an anti-CD38 treatment developed by Sanofi, has been approved in China for treating adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least one prior therapy. The approval is based on the … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged anti-CD38 antibody, autologous stem cell transplant, bortezomib, CACA, Category I Recommendation, Chinese Anti-Cancer Association, Chinese Society of Clinical Oncology, clinical data, CSCO, dexamethasone, Global Head of Oncology, ICARIA-MM phase 3 study, innovative regulatory pathways, innovative therapies, IsaFiRsT real-world study, Lecheng Pilot Program, lenalidomide, local authorities, medical community, National Medical Products Administration, newly diagnosed multiple myeloma, NMPA, Olivier Nataf, overall response rate, overall survival, Pd, pomalidomide, R/R MM, real-world evidence, regulatory submission, relapsed or refractory multiple myeloma, RWE, Sanofi, Sanofi in China, Sarclisa
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