• Pfizer's PARP inhibitor Talzenna has gained European approval when used in combination with Pfizer and Astellas' Xtandi to treat adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

This approval makes Talzenna the first PARP inhibitor in Europe to be licensed in combination with Xtandi in mCRPC, Pfizer said in a release.

The European Commission approved Pfizer's application based on data from the phase 3 TALAPRO-2 trial, which showed that the combo cut the risk of disease progression or death in patients with mCRPC compared with placebo and Xtandi.

Last June, the FDA approved the combination to treat adults with HRR gene-mutated mCRPC.

• In another regulatory win for Pfizer, the FDA is reviewing the company's full approval application on Genmab-partnered Tivdak.

Under its priority review timeline, the FDA is assessing whether to convert Tivdak's accelerated approval into a full nod to treat patients with recurrent or metastatic cervical cancer who've had disease progression on or after first-line therapy.

The FDA plans to act on the filing by May 9, Pfizer said.

• Eisai and Biogen's Alzheimer's disease drug Leqembi has picked up an approval in China to treat patients with mild disease.

Eisai estimates there will be 17 million patients in China in 2024 who could be eligible for Leqembi based on the med's current label. And the med's popularity is expected to grow as the population ages.

"Eisai will focus on AD awareness via omnichannel systems and collaborate with specialists to improve the diagnostic environment," the company said.

• Amid Sarepta's early launch of Duchenne muscular dystrophy gene therapy Elevidys, the company is aiming for a significant label expansion.

In an update (PDF) at the J.P. Morgan Healthcare Conference, Sarepta argued that late-stage clinical data on the medicine "exceeded the threshold for substantial evidence of effectiveness" and that the drug's risk/benefit profile "remains favorable." Sarepta is expecting a decision by the FDA on its expansion bid by August, the company said.

Elevidys won an accelerated FDA approval back in June to treat ambulatory DMD patients ages 4 to 5 years with a confirmed mutation in the DMD gene. After that accelerated approval and subsequent trial results, the company is pursuing an FDA nod to treat all patients.

This week, analysts with Mizuho said they "believe the odds are high for the label expansion," according to Investing.com.

UPDATED: Friday, Jan. 5 at 9:35 a.m.
• After last year's approval from the U.S. FDA, Pfizer's RSV vaccine Abrysvo has secured an approval from Health Canada.

Regulators in Canada endorsed the vaccine for use in adults 60 years of age and older to prevent lower respiratory tract disease caused by RSV. In addition, the agency signed off on the vaccine's use in people who are between 32 and 36 weeks pregnant to protect their infants after they're born.

Canada's National Advisory Committee on Immunization is conducting its own review of the vaccine and will issue guidelines around using the vaccine in Canada.

GSK's Arexvy is also approved in Canada for use in people 60 and older.

• Ultragenyx's Evkeeza has picked up a coverage recommendation in England.

The National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending the medicine, plus diet and other LDL-C therapies, for the treatment of adults and children 12 and older with homozygous familial hypercholesterolemia (HoFH).

Ultragenyx points out that the drug is the first angiopoietin-like 3 inhibitor for the disease.

In 2022, the company inked a deal with the drug's developer, Regeneron, to commercialize Evkeeza outside the U.S.

UPDATED: Wednesday, Jan. 3 at 9:30 a.m.
• After two decades of stagnation, the United Kingdom's Medicines & Healthcare products Regulatory Agency (MHRA) has welcomed a new endocrine therapy into the cancer fighting fold.

Now dubbed Korserdu, Menarini Group's small molecule drug has been cleared in the U.K. as the first medicine to treat ER+, HER2- advanced or metastatic breast cancer tumors with ESR1 mutations. The drug is specifically authorized for postmenopausal women and men who've already tried at least one line of endocrine therapy, including a CDK 4/6 inhibitor.

ESR1 mutations are acquired mutations that develop from exposure to endocrine therapy, which drive resistance to standard endocrine therapy.

Korserdu helped patients with ESR1 mutations hit a median progression-free survival of 3.8 months versus 1.9 months for those on standard of care. The treatment also reduced the risk of progression or death by 45% compared to standard of care.

Korserdu's U.K. green light comes several months after the medicine won marketing authorization in the European Union under the brand name Orserdu.

• Elsewhere, the European Medicines Agency (EMA) accepted Bristol Myers Squibb's application for potential approval of its next-generation tyrosine kinase inhibitor (TKI) repotrectinib. The drug is angling for approval in locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) and NTRK-positive solid tumors.

BMS girded its application with data from the phase 1/2 Trident-1 trial, as well as the pediatric Care study. The clutch of clinical trials shows repotrectinib charted clinically meaningful response rates in patients across ROS1-positive NSCLC and NTRK-positive solid tumor cohorts.

Back in November, the U.S. FDA approved repotrectinib as Augtyro to treat adult patients with locally advanced or metastatic ROS1-positive NSCLC.

• Speaking of the FDA, the U.S. drug regulator late last month approved Coherus BioSciences' Udenyca Onbody delivery system for its biosimilar to Amgen's febrile neutropenia drug Neulasta.

Coherus' copycat, dubbed Udenyca, is given to patients the day after chemotherapy to curb infections caused by febrile neutropenia.

The company's Onbody delivery system tees up administration of pegfilgrastim in just five minutes. The delivery system also features an indicator and status light, plus an audio signal that helps patients confirm the dose has been administered.

Coherus expects to make its Udenyca Onbody delivery system available in the U.S. during 2024's first quarter.

https://www.pharma.com/pharma/pharma-regulatory-tracker-2024