Cancer

The companies presented 52-week data from the pivotal Phase III VERIFY study at the recent American Society of Hematology meeting, after releasing 32-week data earlier this year.

The drugmaker presented multiple posters of data for the recently reapproved BCMA-targeting antibody-drug conjugate at the just concluded ASH meeting.

Lupeng's BTK inhibitor rocbrutinib has shown an 80.0% ORR in a Phase I trial in patients who had received a covalent or non-covalent BTK inhibitor plus BCL-2 inhibitor, setting the stage for a comparative trial, possibly with Jaypirca.

J&J's late-breaking Phase III MajesTEC-3 data at the American Society of Hematology meeting highlighted curative potential for the bispecific T-cell engager in multiple myeloma.

To develop bispecific, dual-payload antibody-drug conjugates, Phrontline Biopharma’s strategy is to tune the activity of each payload to a similar level and engineer both toxins to fit within a branched linker, its CEO tells Scrip in an interview.

Data from the Phase III BRUIN CLL-313 trial presented at ASH showed clear superiority for the non-covalent BTK inhibitor as a single agent compared with bendamustine/rituximab.

The company presented Phase II results at ASH that lend support to an ongoing Phase III trial of the CELMoD drug in maintenance therapy of multiple myeloma.

FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.

The company plans to take IGV-001 to the FDA after the mid-stage trial showed a more than six-month improvement in overall survival compared with placebo.

The US FDA’s accelerated approval makes sevabertinib the second drug for that patient segment after BI’s Hernexeos, which won accelerated approval in August.

The European Medicines Agency has begun evaluating the EU marketing applications for a new batch of drugs, including products from Incyte, Sanofi and Novo Nordisk that target hidradenitis suppurativa, rabies and hemophilia A, respectively.

Sichuan Biokin Pharmaceutical's BMS-partnered bispecific antibody-drug conjugate iza-bren had met both endpoints of PFS and OS in a China-only Phase III trial for the second-line treatment of esophageal squamous cell carcinoma.