FDA Action Alert: BMS, Eton, Provention and Lantheus


It’s a busy week for the U.S. Food and Drug Administration (FDA), with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.

Bristol Myers Squibb’s Opdivo for Gastric Cancer

Bristol Myers Squibb had a target action date of May 25, 2021, for its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC). The sBLA was approved on April 16. The submission was based on data from the CheckMate -649 trial and was granted Priority Review. The trial demonstrated that first-line treatment with Opdivo and FOLFOX or CapeOX led to a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) for this patient population compared to chemotherapy alone.

“We are focused on bringing transformative medicines to patients in need, and historically, there has been little progress for patients diagnosed with these metastatic gastroesophageal adenocarcinomas,” said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb. “As demonstrated in the CheckMate -649 trial, Opdivo is the first and only immunotherapy combined with chemotherapy to deliver superior overall survival versus chemotherapy alone in first-line metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.”

Bristol Myers Squibb’s Zeposia for Ulcerative Colitis

Bristol Myers Squibb also has a target action date of May 30 for its supplemental New Drug Application (sNDA) for Zeposia (ozanimod) for adults with moderately to severely active ulcerative colitis (UC). It was redeemed via a Priority Review Voucher. The sNDA was built on data from True North, a pivotal Phase III trial looking at the drug as an induction and maintenance therapy in adults with moderately to severely active UC. The study met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at Week 10 and in maintenance at Week 52.

Eton’s Dehydrated Alcohol Injection and Zonisamide

Eton Pharmaceuticals has a target action date of May 27 for its New Drug Application for dehydrated alcohol injection. This is an orphan drug designation for the treatment of methanol poisoning. The company also has a target action date of May 29 for Zonisamide Oral Suspension. Zonisamide is an oral liquid to treat partial seizures in patients with epilepsy.

In its capsule form, zonisamide is widely used to treat partial seizures. Eton’s technology liquid formulation, the company says, “addresses the significant unmet need for patients with dysphagia and patients that require a precision dosing that a liquid product offers.”

Endocrine Advisory Committee Meets to Discuss Provention’s Teplizumab for Type 1 Diabetes

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee is meeting on May 27 to review Provention Bio’s BLA for teplizumab intravenous infusion. The drug is being proposed as a way to delay or prevent clinical type 1 diabetes mellitus in at-risk (Stage 2) individuals.

In the company’s first-quarter financial report on May 6, Ashleigh Palmer, Provention’s chief executive officer said, “Our near-term focus is appropriately concentrated on the BLA filing for teplizumab and the upcoming FDA Advisory Committee meeting on May 27. We believe this Advisory Committee meeting’s agenda will include examination of type 1 diabetes unmet need and the safety and efficacy of teplizumab for the TN-10 trial supported by data from other historic studies in newly diagnosed patients.”

On April 27, Provention indicated that it had taken part in an informal meeting with the FDA on April 23 in connection to the BLA. They discussed the FDA’s considerations about comparability between the drug and the drug produced historically and used in clinical trials that originated from a drug manufactured by Eli Lilly over a decade ago. The FDA decided that the pharmacokinetic profiles of the two drugs that were evaluated in Provention’s single-dose PK/PD bridging study in healthy volunteers were not comparable, since their drug did not meet the pre-specified 80-125% PK area under the curve (AUC) comparability target range. The FDA said it understood the high unmet need and was willing to work with Provention to find a solution and path forward. As a result, Provention repeated guidance that this might lead to a delay in approval timelines.

Lantheus’ PyL PET Imaging Agent for Prostate Cancer

Lantheus Holdings has a target action date of May 28 for its NDA for PyL, a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent for prostate cancer. It was granted Priority Review and an advisory committee meeting is not expected to be held.

The NDA was supported by data from the OSPREY and CONDOR pivotal trials that established the safety and diagnostic performance of PyL imaging across the prostate cancer disease continuum. PyL enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

At the company’s first-quarter financial report on May 4, Mary Anne Heino, president and chief executive officer, said, “Currently, we are focused on preparation for the potential FDA approval and commercial launch of PyL, a best-in-class PSMA prostate cancer imaging agent, to help drive long-term value for patients, healthcare professionals, and shareholders.”

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