1. Scrip
  2. >>Business

GSK Files Its BCMA Drug In Multiple Myeloma

Filing Underpinned By Good DREAMM-2 results

 
• By Sten Stovall

GSK has filed its anti-BCMA agent with the FDA after full Phase II DREAMM-2 data showed an overall response rate of 31% in patients with heavily pre-treated multiple myeloma.

Multiple_Myeloma
GSK’s Could Become First Anti-BCMA Agent Approved In US • Source: Shutterstock

GlaxoSmithKline PLC has submitted a biologics license application to the US Food and Drug Administration for its anti-B-cell maturation antigen (BCMA) therapy, backed by detailed pivotal Phase II DREAMM-2 results showing the antibody-drug conjugate in late-stage multiple myeloma patients produced a good 31% response rate.

GSK on 16 December said full results from its DREAMM-2, published in The Lancet Oncology, were consistent with those seen in a similar subset of patients in the DREAMM-1 study,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Business

Bristol Will Pay BioNTech $1.5bn Up Front To Enter PD-L1xVEGF Space

 
• By Joseph Haas

BMS is guaranteeing BioNTech at least $3.5bn to share development costs and potential profits on the Phase III bispecific, to compete with Summit, Merck and Pfizer.

Regeneron Buys Tirzepatide-Like Product With Eye On Muscle-Preserving Combinations

 
• By Jessica Merrill

Regeneron is bringing in its own GIP/GLP-1 agonist, establishing a path to develop proprietary obesity drug combinations with its internal muscle-sparing drugs.

Sanofi Plays It Safer With Blueprint Buy After Bumpy 2025

 
• By Kevin Grogan

But the French major is still keen on early-stage M&A.

BREAKING NEWS: Sanofi Bets $9.5bn To Bag Blueprint

 
• By Kevin Grogan

Buy boosts the French major's immunology pipeline.

More from Scrip

ASCO: IO Continues Climb To Earlier Use With AstraZeneca’s MATTERHORN, BMS’s NIVOPOSTOP

 
• By Mary Jo Laffler

Data presented at ASCO supports use of AZ’s Imfinzi for perioperative gastric cancer and BMS’s Opdivo for adjuvant treatment of head and neck cancer.

Regeneron Buys Tirzepatide-Like Product With Eye On Muscle-Preserving Combinations

 
• By Jessica Merrill

Regeneron is bringing in its own GIP/GLP-1 agonist, establishing a path to develop proprietary obesity drug combinations with its internal muscle-sparing drugs.

ASCO: DESTINY-Breast09 Strong, But May Need Mature OS Data To Change Practice

 
• By Alaric DeArment

Data from AstraZeneca/Daiichi’s breast cancer trial showed positive PFS, but some oncologists are waiting for confirmation of statistically significant OS benefit.