Top FDA News of the Week

Advisory panel recommends Pfizer vaccine booster but only for older People, those at high risk

The Vaccines and Related Biological Products Committee voted unanimously yesterday to recommend a booster shot of the Pfizer COVID-19 vaccine for people 65 and older and those at high risk of experiencing a severe case of the disease. But the committee also cast a 16-2 vote against recommending a broader recommendation that would have included people ages 16 and older. The committee of outside experts were also unanimous in their support for a booster for healthcare workers and those at heightened risk of getting COVID-19 at work, although that vote was informal poll of the committee. For the most part, the committee vote was greeted as appropriate and attuned to the data about the protection afforded by the Pfizer vaccine, waning immunity and the risk posed by the Delta variant. The next steps include an FDA decision on whether to follow the advisory committee’s recommendations and consideration of the booster by the CDC’s Advisory Committee on Immunization Practices.

Expanded EUA for bamlanivimab and etesviamb taken together

The FDA has expanded the emergency use authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg, administered together to include post-exposure prophylaxis (PEP) in certain individuals for the prevention of SARS-CoV-2 infection, according to Eli Lilly.The neutralizing antibodies can now be used together to treat high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison, the company said. This authorization follows the national reopening of distribution earlier this month, the company statement said.

FDA approves novel oral therapy for lung cancer

The FDA has approved Takeda Oncology’s Exkivity (mobocertinib) to treat adult patients with locally advanced or metastatic nonsmall cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, according to press release from Takeda on Wednesday (Sept. 15). Exkivity, which was granted priority review and received breakthrough therapy designation, fast track designation, and orphan drug designation from the FDA, is the first approved oral therapy to target EGFR exon 20 insertion mutations.

This indication is approved under accelerated approval based on overall response rate and duration of response. The FDA approval is based on results from the platinum-pretreated population in the phase 1/2 trial of Exkivity in patients who had received prior platinum-based therapy.

The FDA also approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to identify patients who are candidates for Exkivity. The test evaluates 23 genes associated with NSCLC.

Brukinsa snags third FDA approved indication, this time for lymphoma

The FDA has approved BeiGene’s Brukinsa (zanubrutinib) as a second-line treatment of adult patients with relapsed or refractory marginal zone lymphoma, a group of slow-growing non-Hodgkin lymphomas.

Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase, which plays a role in B-cell receptor signaling, a driver in the development of marginal zone lymphoma. Marginal zone lymphoma is a rare disease. About 7500 new cases are diagnosed in the U.S. each year.

.The recommended dose is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. Brukinsa was approved by the FDA in November 2019 for the treatment of mantle cell lymphoma in adult patients who have received at least and in August 2021 for adult patients with Waldenström’s macroglobulinemia.

FDA accepts BLA for tislelizumab for second-line esophageal cancer

The FDA has accepted the biologics license application (BLA) for the BeiGene’s anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma after prior systemic therapy. The Prescription Drug User Fee Act date — the date by which the FDA is supposed to make a decision whether to appovee the drug — is July 12, 2022. Earlier this year, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.

Investigational oral migraine treatment closer to full FDA approval

The FDA has accepted Axsome Therapeutics’ new drug application (NDA) for meloxicam-rizatriptan (AXS-07) for the treatment of acute migraine, bringing the novel investigational medication one step closer to full FDA approval.

Meloxicam-rizatriptan is a novel, oral, rapidly absorbed therapy for migraine, Axsome said in a press release. It is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence, according to the company.

The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2022, for the NDA.

Meloxicam is a new molecular entity enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption while maintaining a long half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5-HT1B/1D agonist.