Innovation Passport granted to Pfizer's MM candidate by MHRA

Elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma (MM) by US pharma giant Pfizer (NYSE: PFE), has been granted an ‘Innovation Passport’ from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

The Innovation Passport is the entry point to the MHRA’s new Innovative Licensing and Access Pathway (ILAP), intended to offer regulatory support and flexibilities to bring new medicines to UK patients more quickly. In June this year, the MHRA granted the same ‘passport’ for GSK’s (LSE: GSK) Blenrep (belantamab mafodotin) for the treatment of multiple myeloma.

In a Phase II MagnetisMM-3 registration-enabling trial of elranatamab in people with relapsed/refractory multiple myeloma, initial efficacy results showed that the objective response rate for elranatamab was 60.6%. As of the data cut-off, 89.5% of objective responders were ongoing without confirmed progression or death. The results also suggested 76 mg of elranatamab weekly may have a manageable safety profile in patients with triple-class refractory MM.