Top FDA News of the Week

Advisory group recommends Pfizer vaccine booster, but only for the elderly, those at high risk

The Vaccines and Related Biologics Committee voted unanimously yesterday to recommend a booster of the Pfizer COVID-19 vaccine for people 65 years of age and older and those at high risk of suffering from a severe case of the disease. But the committee also voted 16-2 against recommending a broader recommendation that would have included people aged 16 and over. The committee of external experts was also unanimous in supporting a recall for healthcare workers and those at increased risk of contracting COVID-19 at work, although this vote is an informal poll of the committee. For the most part, the committee’s vote was welcomed as appropriate and appropriate to the data on the protection offered by the Pfizer vaccine, the decline in immunity and the risk posed by the Delta variant. Next steps include an FDA decision on whether to follow the advisory committee’s recommendations and consideration of the recall by the CDC’s Advisory Committee on Immunization Practices.

ExEUA panded for bamlanivimab and etesviamb taken together

The FDA has extended the Emergency Use Authorization (EUA) for bamlanivimab 700 mg and etesevimab 1400 mg, administered together to include post-exposure prophylaxis (PEP) in some people for the prevention of SARS infection -CoV-2, according to Eli Lilly. 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 who are not expected to develop an adequate immune response to complete the vaccination, and who were exposed to someone infected with SARS-CoV-2 or 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, according to the company’s press release.

FDA approves new oral therapy for lung cancer

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

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

The FDA also approved Thermo Fisher Scientific’s Oncomine Dx assay targets as a companion diagnostic to identify patient candidates for Exkivity. The test evaluates 23 genes associated with NSCLC.

Brukinsa lands third FDA-approved indication, this time for lymphoma

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

Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor, which is involved in the signaling of B cell receptors, a driver in the development of marginal zone lymphoma. Lymphoma of the marginal zone is a rare disease. About 7,500 new cases are diagnosed in the United States each year.

The recommended dose is 160 mg twice a day or 320 mg once a day, taken by mouth with or without food. Brukinsa was approved by the FDA in November 2019 for the treatment of mantle cell lymphoma in adult patients who 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 BeiGene’s anti-PD-1 antibody, tislelizumab, as a treatment for patients with unresectable or metastatic recurrent esophageal squamous cell carcinoma after treatment systemic anterior. The date of the Prescription Drug User Fee Act (the date the FDA is supposed to make the decision whether or not to approve the drug) is July 12, 2022. Earlier this year, BeiGene and Novartis reached an agreement collaboration and a license agreement granting Novartis the rights to develop, manufacture and market tislelizumab in North America, Europe and Japan.

Investigational Oral Migraine Treatment Approaches 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 investigational new drug closer to full FDA approval.

Meloxicam-rizatriptan is a new, rapidly absorbing oral treatment for migraine, Axsome said in a press release. It’s designed to provide fast, improved, consistent migraine relief with reduced symptom recurrence, according to the company.

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

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