FDA grants priority reviews for Pfizer’s Prevnar 20 for kids and Roche lymphoma candidate

The FDA granted two priority reviews: one for a potential Pfizer vaccine for kids and the other for Roche’s bispecific antibody glofitamab, the companies announced Friday.

The FDA will review Pfizer’s supplemental biologics license application (sBLA) for the 20-valent vaccine candidate, 20vPnC, which is already approved for adults as Prevnar 20, the company said in a press release. The vaccine is meant to prevent invasive pneumococcal disease caused by Streptococcus pneumoniae bacteria, as well as prevent otitis media ear infections. Infants and children 6 weeks old through 17 years old would be eligible.

Because of the priority review status, the goal date for a decision by the FDA could be as early as April 2023. The vaccine candidate was granted fast track designation in May 2017 and breakthrough designation in August 2020.

Annaliesa Anderson

“By offering the broadest serotype coverage by a pneumococcal conjugate vaccine against important serotypes causing pneumococcal disease in U.S. infants and children, 20vPnc, if approved, can help expand the protection for this vulnerable pediatric population,” said Annaliesa Anderson, Pfizer’s senior vice president and chief scientific officer of vaccine research and development.

Prevnar 20 got the FDA green light as an adult vaccine in June 2021 as well as in the EU, where it’s known as Apexxnar, in February of this year.

Merck has also been working in the valent vaccine space and secured FDA approval for its 15-valent Vaxneuvance for kids in June.

For Roche’s candidate glofitamab, the FDA is expected to make a decision on the bispecific antibody by July 1, the company announced. The drug is for relapsed or refractory large B-cell lymphoma after patients have tried other therapies. It’s a type of non-Hodgkin lymphoma and is one of the most prevalent types of blood cancer among adults in the US.

According to Roche, if approved, glofitamab will be the “first first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with an aggressive lymphoma” for people who have already tried other methods of treatment.

Last month, Endpoints News reported that Biogen will receive tiered royalties on potential net sales of glofitamab within the US and will have no payment obligations if the drug gets approved while Genentech, a member of Roche, largely retains commercial control.

Meanwhile, the closest competitor, AbbVie and Genmab’s competing bispecific epcoritamab, has a May 21, 2023 PDUFA date for third-line R/R large B-cell lymphoma.

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