FDA Issues Complete Response Letter for Myeloma Drug
The US Food and Drug Administration (FDA) has declined to approve linvoseltamab (Regeneron), a bispecific antibody being evaluated to accommodate relapsed/refractory a few myeloma after development on not decrease than three previous therapies.
Tuesday night, Regeneron announced that it had got an total response letter from the FDA concerning its Biologics License Application for linvoseltamab, citing components at a third-decide up together manufacturer.
More particularly, Regeneron said in a company press originate that the FDA issued the total response letter in accordance with findings from “a preapproval inspection at a third-decide up together beget/attain manufacturer for one more company’s product candidate.”
The third-decide up together manufacturer urged Regeneron it believes that the components were resolved, Regeneron said, and that facility is now awaiting a notice-up FDA inspection within the “coming months.”
Regeneron illustrious that this “anticipated final consequence” from the FDA preapproval inspection had been disclosed beforehand within the direction of a company earnings name on August 1.
On that name, Regeneron had discussed the FDA’s considerations about the third-decide up together manufacturer and anticipated that “any likely FDA acclaim for linvoseltamab is inclined to be delayed beyond the August 22 PDUFA date.”
Regeneron had before the whole lot filed a Biologics License Application for its bispecific antibody in 2023, in accordance with findings from the half 1/2 single arm LINKER-MM1 trial.
In the most contemporary printed trial findings, investigators reported that, at a median notice-up of about 14 months, 71% of the 117 patients receiving 200 mg of linvoseltamab completed an total response, with 50% achieving an total response. The possibility of survival at one year turn out to be once 75.3%.
This would were the first acclaim for linvoseltamab, which would perchance perchance well gain joined two agents already on the US market for relapsed/refractory a few myeloma: teclistamab (Tecvayli, Janssen) and elranatamab (Elrexfio, Pfizer).
Pricing files for linvoseltamab isn’t but within the market, but its opponents teclistamab and elranatamab are reported to charge round $40,000 per month.
