GSK's Blenrep Receives Canadian Approval for New Multiple Myeloma Indication

GSK has announced that its antibody-drug conjugate Blenrep has been approved in Canada for a new indication in patients with relapsed or refractory multiple myeloma. The approval allows for its use in combination with bortezomib and dexamethasone, or pomalidomide and dexamethasone, for patients who have received at least one prior line of therapy, including lenalidomide. Multiple myeloma is a treatable but incurable blood cancer.

GSK has announced that its antibody-drug conjugate Blenrep (belantamab mafodotin for injection) has been approved in Canada for a new indication in patients with relapsed or refractory multiple myeloma. The approval allows for its use in combination with bortezomib and dexamethasone, or pomalidomide and dexamethasone, for patients who have received at least one prior line of therapy, including lenalidomide.

The approval is based on the results of two pivotal phase III clinical trials, DREAMM-7 and DREAMM-8, which demonstrated superior efficacy compared to standard of care. The trials showed statistically significant and clinically meaningful progression-free survival (PFS) results and overall survival (OS) improvements in favor of the Blenrep combinations.

Blenrep is the first and only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) for multiple myeloma, offering patients facing their first and subsequent relapses a differentiated mechanism of action. The approval marks a significant milestone in the treatment landscape for multiple myeloma, a challenging condition characterized by repeated cycles of remission and relapse.

Multiple myeloma is the third most common blood cancer globally, with approximately 180,000 new cases diagnosed annually. In Canada, over 4,000 people were diagnosed with the disease in 2024 alone. The availability of diverse treatment options like Blenrep is vital for prolonging remission and enhancing survival outcomes.

The most common adverse reactions associated with Blenrep include reduced visual acuity, corneal examination findings, blurred vision, dry eye, photophobia, and others. These side effects are manageable with extended time between infusions and dose reductions, leading to low treatment discontinuations.

GSK's approval of Blenrep in Canada represents an advancement for patients with multiple myeloma, providing them with a differentiated treatment option that holds the promise to transform the therapeutic approach for those facing their first or subsequent relapses.

References:
[1] https://www.biospace.com/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-canada-for-the-treatment-of-relapsed-refractory-multiple-myeloma