B-cell maturation antigen (BCMA)

Bristol Myers Takes $470 Million Write-off and Scraps Orva-Cel CAR-T Program

B-cell maturation antigen (BCMA), Biologics License Application (BLA), Bristol Myers Squibb, Business, CAR-T Therapy, Clinical Trials, PDUFA, R&D, Relapsed Or Refractory (R/R) Large B-Cell Lymphoma (LBCL), Therapeutics, Write-offs

Bristol Myers Squibb reported that the company was abandoning the BCMA CAR-T therapy orva-cel and taking a $470 million write-off.

February 11, 2021/by Andrew Humphreys

Can Janssen Cure Cancer? Company’s 80+ ASH Presentations Suggest It’s On Right Track

American Society of Hematology (ASH) Annual Meeting, B-cell maturation antigen (BCMA), Cancer, Clinical Data, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, Hematology, Janssen, Johnson & Johnson, R&D, Relapse/Refractory Multiple Myeloma, T-Cells, Therapeutics

The Janssen Pharmaceutical Companies of Johnson & Johnson has a presence in more than 80 of the hematology studies presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition in December.

December 4, 2020/by BioSpace

FDA Accepts BLA for bluebird and BMS’ Multiple Myeloma CAR-T Treatment

B-cell maturation antigen (BCMA), Biologics License Application (BLA), Biologics License Application (BLA) Review Acceptance, CAR-T Therapy, Clinical Trials, FDA/Regulatory, Immunotherapies, PDUFA, Priority Review Status, R&D

Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review for idecabtagene vicleucel.

September 22, 2020/by BioSpace

Celyad’s High Hopes for a Path Forward in Cancer Immunotherapy with CYAD-211

B-cell maturation antigen (BCMA), Biotechnology, CAR-T Therapy, Cell Therapy, Clinical Trials, Gene Editing, Immunotherapies, Metastatic Colorectal Cancer (mCRC), Oncology, R&D, Relapse/Refractory Multiple Myeloma

Celyad Oncology is at the forefront of cutting-edge immunotherapy and is hopeful of providing a new way forward for patients with relapsed/refractory multiple myeloma.

September 2, 2020/by BioSpace

GSK’s blood cancer drug wins European panel thumbs-up

Antibody-Drug Conjugates (ADCs), B-cell maturation antigen (BCMA), Blockbusters, Blood Cancers, Cells, Chemotherapy, European Medicines Agency, FDA/Regulatory, Immunomodulatory Agents, Recommended For Approval, Relapse/Refractory Multiple Myeloma

A panel of the European Medicines Agency recommended approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, days after a similar nod from a U.S. Food and Drug Administration panel.

July 24, 2020/by Reuters Health

FDA panel votes in favor of approving GSK’s multiple myeloma drug

Advisory Panels, Antibodies, Antibody-Drug Conjugates (ADCs), B-cell maturation antigen (BCMA), Blood Cancers, Drug Safety Concerns, FDA, FDA/Regulatory, Multiple Myeloma

An independent panel to the U.S. Food and Drug Administration voted in favor of approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, saying the benefits of the treatment outweigh the risks.

July 14, 2020/by Reuters Health

FDA Declines Review of Bristol Myers Squibb and bluebird’s Multiple Myeloma Therapy

B-cell maturation antigen (BCMA), Biologics License Application (BLA), Business, CAR-T Therapy, Collaborations, FDA, FDA/Regulatory, Immunotherapies, Investors, Refusal to File letter, Relapse/Refractory Multiple Myeloma, Shareholders, Shares

Shares of bluebird bio were down in trading after the U.S. Food and Drug Administration declined to review a Biologics License Application for the experimental CAR-T treatment idecabtagene vicleucel for multiple myeloma co-developed with Bristol Myers Squibb.

May 13, 2020/by BioSpace

GSK Submits Multiple Myeloma Drug to Regulators

B-cell maturation antigen (BCMA), Biologics License Application (BLA), Blockbusters, Blood Cancers, FDA, FDA/Regulatory, Health Technology, Immunoconjugates, Monoclonal Antibodies, Multiple Myeloma, Overall Response Rate (ORR)

GlaxoSmithKline submitted a Biologics License Application to the U.S. FDA based upon results from the pivotal DREAMM-2 Phase III trial of belantamab mafodotin in multiple myeloma.

December 17, 2019/by BioSpace

GSK builds oncology pipeline as drug shown to help myeloma patients

B-cell maturation antigen (BCMA), Blood Cancers, Breast Cancer, Business, Cancer, Clinical Trials, Immunotherapies, Multiple Myeloma, Product Pipeline, R&D, Shares, White Blood Cells

GlaxoSmithKline said an experimental multiple myeloma treatment showed a meaningful response in patients that have run out of three previous treatment options.

August 23, 2019/by Reuters Health

AbbVie and Teneobio Announce a Strategic Transaction to Develop a New Treatment for Multiple Myeloma

B-cell maturation antigen (BCMA), Biotech, Bispecific Antibody, Business, Clinical Trials, Immunotherapeutics, Multiple myeloma, R&D, T-Cells

AbbVie Inc., along with Teneobio Inc. and that company’s affiliate TeneoOne Inc., announced that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma.

February 11, 2019/by PR Newswire