Six weeks after the U.S. FDA issued an alert, the EMA is following suit and starting a review of the safety of six approved CAR T-cell cancer therapies, following 23 reports of patients developing secondary cancers. The EMA said such malignancies were considered “an important potential risk” at the time of approval and are included in the risk management plan. Close monitoring is in place, with companies required to conduct long-term safety and efficacy follow-up studies and to file safety update reports.

U.S. biopharma Sermonix Pharmaceuticals Inc. handed off China rights of lasofoxifene, an oral endocrine therapy in development for breast cancer, to Shanghai’s Henlius Biotech Inc., for an undisclosed up-front payment and up to $58 million in milestone fees.

Biocytocgen Pharmaceuticals (Beijing) Co. Ltd. has entered into an exclusive option and license agreement with Radiance Biopharma Inc., granting Radiance an option to license from Biocytogen a first-in-class fully human anti-HER2/TROP2 bispecific antibody-drug conjugate (BsADC).

A landmark, real-world study in the U.K. has demonstrated that combining whole genome sequencing with clinical data enabled tailored cancer treatment and improved outcomes. At one health care center, having DNA sequence data led to changes from usual standard of care in 25% of cases. “Mostly, [patients] got into clinical trials; some got medicines they wouldn’t have got. Others avoided medicines because their genetic make-up suggested that if they were exposed to the medicines, they would be at risk of harm,” said Mark Caulfield, professor of clinical pharmacology at Queen Mary University of London, who is co-author of a paper outlining the findings in Nature Medicine, Jan 11, 2024.

With a sizeable series B financing well underway, Actimed Therapeutics Ltd. is preparing to advance its compound, S-pindolol benzoate (ACM-001), into a phase IIb/III trial to treat cachexia secondary to colorectal cancer, having also recently completed a £4.75 million (US$5 million) series A extension round.