4+ day, 6+ hour ago   (562+ words) Bayer has won FDA approval for oral HER2 inhibitor Hyrnuo as a first-line treatment for advanced HER2-mutant non-small cell lung cancer (NSCLC), just a year after it was cleared as a second-line option. Hyrnuo (sevabertinib) has been cleared for earlier use…...

5+ day, 4+ hour ago   (548+ words) BMS CAR-T scientists at work. Bristol Myers Squibb's GPRC5D-directed CAR-T therapy, arlocabtagene autoleucel (arlo-cel), has shown activity in a phase 2 trial that could underpin future filings for blood cancer multiple myeloma. The pivotal QUINTESSENTIAL trial of the potentially first-in-class CAR-T…...

5+ day, 3+ hour ago   (427+ words) Amgen's fast-growing cancer immunotherapy Imdelltra could move into the first-line setting in small cell lung cancer (SCLC), after delivering as a dual regimen with AstraZeneca's Imfinzi in the DeLLphi-305 study. The trial compared the combination as a first-line maintenance therapy…...

6+ day, 2+ hour ago   (195+ words) With 18+ data-led presentations on complement-based modalities including siRNA, gene therapies, novel biologics and small molecules, this 10th Anniversary forum will share the latest breakthroughs and strategies within complement science, enabling you to progress your own therapeutic pipeline with confidence. Take a…...

1+ week, 6+ hour ago   (603+ words) The EU Health Technology Assessment (HTA) Regulation became applicable on 12th January 2025, marking a fundamental shift in how clinical evidence for new health technologies is assessed across Europe. Until recently, however, much of the discussion around the JCA has focused on…...

1+ week, 4+ day ago   (446+ words) Akeso and Summit's PD-1xVEGF drug ivonescimab has improved overall survival (OS) in another phase 3 trial, this time when used as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC). The results come from the HARMONi-2 trial carried out…...

1+ week, 5+ day ago   (496+ words) PMV Pharma is preparing to file for approval of its oral p53 protein reactivator drug rezatopopt in the first quarter of 2027, after reporting positive results in a phase 2 trial in ovarian cancer. That schedule means Princeton, New Jersey-based PMV has a…...

1+ week, 5+ day ago   (474+ words) Over the past decade, immuno-oncology proved a crucial point: given the right direction, the human immune system can recognise and destroy cancer cells. Therapies like checkpoint inhibitors and first-generation CAR-T cells transformed how we think about treatment. But as these…...

1+ week, 5+ day ago   (420+ words) AstraZeneca and Daiichi Sankyo's Enhertu, given in combination with Roche's Perjeta, has become the first new frontline therapy for unresectable or metastatic HER2-positive breast cancer in the EU for over a decade. Enhertu (trastuzumab deruxtecan) and Perjeta (pertuzumab) have been…...

1+ week, 6+ day ago   (360+ words) Novartis has paused eight clinical trials of its experimental CAR-T therapy rapcabtagene autoleucel (rap-cel or YTB323) after three patients died from a severe, life-threatening inflammatory condition. The CD19-directed CAR-T, which uses the same CAR construct as Novartis' already-marketed Kymriah (tisagenlecleucel), but…...