FDA Accepts GSK's BLA for Blenrep Combos in Multiple Myeloma [Yahoo! Finance]
Immunocore Holdings plc - American Depositary Shares (IMCR)
Company Research
Source: Yahoo! Finance
The BLA seeks the approval of Blenrep in combination with J&J's Velcade (bortezomib) plus dexamethasone (BorDex) or Bristol Myers' Pomalyst (pomalidomide) plus dexamethasone (PomDex) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy. With the FDA accepting the BLA for review, a decision from the regulatory body is expected on July 23, 2025. Year to date, shares of GSK have lost 7.9% compared with the industry's 9% decline. Image Source: Zacks Investment Research The BLA for the Blenrep combo was based on data from the III DREAMM-7 and DREAMM-8 studies, both of which met their primary endpoints of progression-free survival (PFS). Data from both studies showed that treatment with the Blenrep combo led to statistically significant and clinically meaningful improvements in PFS versus standard-of-care triplet combinations in RRMM patients. Data from a subsequent interim analysis of the DREAMM-7 study showed that treatment
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IMCR
Earnings
- 11/6/24 - Beat
IMCR
Sec Filings
- 1/3/25 - Form 4
- 1/2/25 - Form 8-K
- 11/14/24 - Form SC
- IMCR's page on the SEC website