Fierce Pharma Asia—Leqembi's priority review; Enhertu's broad trial win; Cipla's FDA censure

The FDA has granted Eisai and Biogen's Leqembi a priority review. AstraZeneca and Daiichi Sankyo's Enhertu may be nearing a tumor-agnostic use. Plus more.

1. Eisai, Biogen's high-stakes Leqembi filing nets FDA priority review—and an AdComm hearing

Thanks to an FDA priority review, Eisai and Biogen will know the agency's decision on a full approval for Alzheimer’s disease drug Leqembi by July 6. A full nod could potentially open the door to a wider Medicare coverage policy.

2. AZ, Daiichi's Enhertu posts trial win in numerous cancer types. Is a tumor-agnostic approval next?

Partners AstraZeneca and Daiichi Sankyo said Enhertu showed an ability to shrink tumors across multiple HER2-expressing cancer types in a phase 2 trial. The trial included biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and rare cancers. Its results could potentially support an FDA filing for a tumor-agnostic indication.

3. Cipla facility hit with scathing FDA report detailing shoddy record-keeping, power outages and more

The FDA cited a Cipla manufacturing facility in Pithampur, India, in a 23-page Form 483 filing. An inspection in February found Cipla failed to properly examine the thousands of customer complaints it had received. Inspectors also found a truck loaded with “bags of scrap” of documents.

4. Astellas Xospata comes up short again in bid to expand leukemia use

Astellas’ Xospata has failed again, this time as a maintenance therapy following a stem cell transplant in a subtype of acute myeloid leukemia (AML) with FLT3-ITD mutations. The drug had previously failed to add benefit to azacitidine in newly diagnosed FLT3-mutated AML.

5. Sun Pharma suffers IT breach, says core systems not affected

Sun Pharma disclosed that it suffered an IT security breach. The company quickly isolated the affected areas, saying the incident didn’t affect its core systems. It’s investigating the situation, Sun said in a securities filing. Cyberattacks have previously been reported at Novartis, Merck & Co. and other drugmakers.

6. Harbour ships phase 3 data to take lead over argenx, J&J and UCB in Chinese autoimmune race

Harbour BioMed’s anti-FcRn drug batoclimab has met its goal in a generalized myasthenia gravis trial in China. The drug could be a direct competitor to argenx’s Vyvgart. Meanwhile, companies such as Johnson & Johnson and UCB are working on drugs with the same mechanism of action. Immunovant holds ex-China rights to batoclimab.

7. Sino Biopharm’s $161M F-star buy clears CFIUS, deal finally closes (release)

After significant delays, Sino Biopharm’s invoX Pharma has finally won an approval from the Committee on Foreign Investment in the United States to take over F-star Therapeutics for $161 million. The deal has closed following the nod. It’s not clear what the Chinese company offered to relieve the agency’s national security concerns. F-star develops bispecific antibody candidates.