The U.S. FDA granted accelerated approval to Amgen Inc.’s Imdelltra (tarlatamab) for treating adults with extensive-stage small-cell lung cancer with disease progression on or after platinum-based chemotherapy. The half-life extended bispecific T-cell engager molecule designed to target delta-like ligand 3 (DLL3) is the first T-cell engager therapy that activates a patient’s own T cells approved by the FDA for this aggressive, solid tumor cancer. DLL3 is an inhibitor ligand of the Notch pathway associated with tumorigenesis. Tarlatamab had a priority BLA with a June 12 PDUFA date. The approval was based on phase II study results in patients who had failed two or more treatment lines.

FDA issues CRL on rivoceranib-camrelizumab combo in liver cancer 

South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer. The FDA initially accepted the NDA of HLB’s oral tyrosine kinase inhibitor, rivoceranib, in combination with Hengrui’s PD-1 inhibitor, camrelizumab, in July 2023. Filed by HLB’s U.S. subsidiary, Elevar Therapeutics Inc., the NDA sought approval in first-line treatment for unresectable hepatocellular carcinoma. The PDUFA date was May 16, 2024.

Verastem combo phase II puts LGSOC in crosshairs

Verastem Oncology Inc.’s dual approach in low-grade serious ovarian cancer (LGSOC) – which has potentially registrational phase II data due soon – was one of the topics of a recent key opinion leader talk hosted by Cantor Fitzgerald. Gynecological oncologist Kathleen Moore, associate director of clinical research at the Stephenson Cancer Center in Oklahoma City, outlined LGSOC and available treatments. Verastem is pairing small molecule avutometinib (VS-6766), a kinase inhibitor that binds to and inhibits the kinase activities of RAF and MEK to block the signal transduction pathways they mediate, with defactinib (VS-6063), an inhibitor of FAK.

US FDA continues high pace in April with 26 drug approvals 

In April, the U.S. FDA approved 26 new drugs, the sixth-highest monthly total going back to 2016. This is slightly lower than March’s record-setting 30 approvals, the highest count in BioWorld’s records. By comparison, the FDA approved an average of about 16 drugs per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.

Economics cited as a driver of worsening drug, device shortages

The U.S. FDA is not the only regulatory agency attempting to deal with impending and existing drug and device shortages, although some of the drivers of these shortages are not with these agencies’ purview. The FDA’s Jacqueline Corrigan-Curay told an audience at the Food & Drug Law Institute meeting in Washington that the poor payment rates offered by payers for generic drugs are a significant contributor, adding that there are instances in which the per-dose rate paid for one of these generics is less than the typical charge for a cup of coffee.

BioWorld Insider Podcast: Fibrobiologics walks the unconventional financing path

A non-traditional route for financing has been the path to success for Fibrobiologics Inc. In the newest BioWorld Insider podcast, CEO Pete O’Heeron offers insight into the company’s unusual path to a Nasdaq listing in January. SPACs, reverse mergers and traditional IPOs weren’t attractive enough for Fibrobiologics’ management or board, so they decided to go public through a direct listing with no banks as underwriters. It took about seven months to get the company ready for its listing, an around-the-clock effort that O’Heeron said was worth the effort. “We couldn’t be more happy with the outcome,” he said.

BioWorld reader feedback needed: Cyberattack impact survey

The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Are there downstream impacts that are being overlooked in the biopharmaceutical and/or medical technology sectors? Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here.

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A2, Accelerated, Agenus, Apogee, Arrivent, Arvinas, Astrazeneca, Aulos, Avenue, Biogen, Bristol Myers Squibb, Carisma, Dermata, Eli Lilly, Erasca, Evōq, First Wave, Flamingo, Fortrea, Genentech, Hutchmed, Immunome, Innocare, Ionis, Kira, Merck, Moonlake, Morphosys, Novartis, Oragenics, Pfizer, Seelos, Spanios, Telix, Tevogen, Totus, Tourmaline, Voyager