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On August 20, Regeneron announced that it had received a complete response letter from the FDA regarding its Biologics License Application for linvoseltamab, citing issues at a third-party manufacturer.
More specifically, Regeneron said in a company press release that the FDA issued the complete response letter based on findings from “a preapproval inspection at a third-party fill/finish manufacturer for another company’s product candidate.”
The third-party manufacturer told Regeneron it believes that the issues have been resolved, Regeneron said, and that facility is now awaiting a follow-up FDA inspection in the “coming months.”
Regeneron noted that this “anticipated outcome” from the FDA preapproval inspection had been disclosed previously during a company earnings call on August 1.
On that call, Regeneron had discussed the FDA’s concerns about the third-party manufacturer and anticipated that “any potential FDA approval for linvoseltamab is likely to be delayed beyond the August 22 PDUFA date.”
Regeneron had initially filed a Biologics License Application for its bispecific antibody in 2023, based on findings from the phase 1/2 single arm LINKER-MM1 trial.
In the latest published trial findings, investigators reported that, at a median follow-up of about 14 months, 71% of the 117 patients receiving 200 mg of linvoseltamab achieved an overall response, with 50% achieving a complete response. The probability of survival at 12 months was 75.3%.
This would have been the first approval for linvoseltamab, which would have joined two agents already on the US market for relapsed/refractory multiple myeloma: teclistamab (Tecvayli, Janssen) and elranatamab (Elrexfio, Pfizer).
Pricing information for linvoseltamab is not yet available, but its competitors teclistamab and elranatamab are reported to cost around $40,000 per month.
A version of this article appeared on Medscape.com.
On August 20, Regeneron announced that it had received a complete response letter from the FDA regarding its Biologics License Application for linvoseltamab, citing issues at a third-party manufacturer.
More specifically, Regeneron said in a company press release that the FDA issued the complete response letter based on findings from “a preapproval inspection at a third-party fill/finish manufacturer for another company’s product candidate.”
The third-party manufacturer told Regeneron it believes that the issues have been resolved, Regeneron said, and that facility is now awaiting a follow-up FDA inspection in the “coming months.”
Regeneron noted that this “anticipated outcome” from the FDA preapproval inspection had been disclosed previously during a company earnings call on August 1.
On that call, Regeneron had discussed the FDA’s concerns about the third-party manufacturer and anticipated that “any potential FDA approval for linvoseltamab is likely to be delayed beyond the August 22 PDUFA date.”
Regeneron had initially filed a Biologics License Application for its bispecific antibody in 2023, based on findings from the phase 1/2 single arm LINKER-MM1 trial.
In the latest published trial findings, investigators reported that, at a median follow-up of about 14 months, 71% of the 117 patients receiving 200 mg of linvoseltamab achieved an overall response, with 50% achieving a complete response. The probability of survival at 12 months was 75.3%.
This would have been the first approval for linvoseltamab, which would have joined two agents already on the US market for relapsed/refractory multiple myeloma: teclistamab (Tecvayli, Janssen) and elranatamab (Elrexfio, Pfizer).
Pricing information for linvoseltamab is not yet available, but its competitors teclistamab and elranatamab are reported to cost around $40,000 per month.
A version of this article appeared on Medscape.com.
On August 20, Regeneron announced that it had received a complete response letter from the FDA regarding its Biologics License Application for linvoseltamab, citing issues at a third-party manufacturer.
More specifically, Regeneron said in a company press release that the FDA issued the complete response letter based on findings from “a preapproval inspection at a third-party fill/finish manufacturer for another company’s product candidate.”
The third-party manufacturer told Regeneron it believes that the issues have been resolved, Regeneron said, and that facility is now awaiting a follow-up FDA inspection in the “coming months.”
Regeneron noted that this “anticipated outcome” from the FDA preapproval inspection had been disclosed previously during a company earnings call on August 1.
On that call, Regeneron had discussed the FDA’s concerns about the third-party manufacturer and anticipated that “any potential FDA approval for linvoseltamab is likely to be delayed beyond the August 22 PDUFA date.”
Regeneron had initially filed a Biologics License Application for its bispecific antibody in 2023, based on findings from the phase 1/2 single arm LINKER-MM1 trial.
In the latest published trial findings, investigators reported that, at a median follow-up of about 14 months, 71% of the 117 patients receiving 200 mg of linvoseltamab achieved an overall response, with 50% achieving a complete response. The probability of survival at 12 months was 75.3%.
This would have been the first approval for linvoseltamab, which would have joined two agents already on the US market for relapsed/refractory multiple myeloma: teclistamab (Tecvayli, Janssen) and elranatamab (Elrexfio, Pfizer).
Pricing information for linvoseltamab is not yet available, but its competitors teclistamab and elranatamab are reported to cost around $40,000 per month.
A version of this article appeared on Medscape.com.