Johnson & Johnson (NYSE: JNJ) today announced groundbreaking topline results from the Phase 3 MajesTEC-9 study, demonstrating that TECVAYLI® (teclistamab-cqyv) monotherapy significantly improves outcomes for [Read More…]
In a potentially practice-changing development for oncology, Merck announced that its Phase 3 KEYNOTE-B15 trial (also known as EV-304) has met its primary and key [Read More…]
A major advance in prostate cancer treatment: The FDA has approved AKEEGA® for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This first-of-its-kind precision therapy, combining niraparib and abiraterone, demonstrated a significant 54% reduction in the risk of disease progression or death compared to the standard of care. This milestone offers a personalized, highly effective option for patients with this aggressive genetic mutation.
GSK’s B7-H3-targeted antibody-drug conjugate, Risvutatug Rezetecan, has been granted Orphan Drug Designation by the US FDA for small-cell lung cancer (SCLC), based on promising early clinical data.
Eli Lilly announced that its non-covalent BTK inhibitor, Jaypirca (pirtobrutinib), met the primary endpoint of non-inferiority on Overall Response Rate (ORR) when compared to Imbruvica (ibrutinib) in the landmark BRUIN CLL-314 Phase 3 trial. The drug demonstrated numerically higher efficacy (87.0% ORR) and a significant safety advantage, including much lower rates of atrial fibrillation/flutter and hypertension, positioning Jaypirca as a potential new front-line therapy for CLL/SLL.
CARVYKTI demonstrated lasting treatment-free remissions at 2.5 years in standard-risk Multiple Myeloma patients treated as early as first relapse in the CARTITUDE-4 study.
U.S. FDA has granted full approval to Eli Lilly’s Jaypirca (pirtobrutinib) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This expanded indication allows the use of the non-covalent BTK inhibitor immediately following prior covalent BTK inhibitor therapy. The decision is bolstered by data from the Phase 3 BRUIN CLL-321 trial, which demonstrated a statistically significant improvement in progression-free survival compared to standard combinatorial therapies.
The FDA has granted approval for PADCEV® plus KEYTRUDA® as a perioperative treatment for cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). Clinical data reveals the combination reduces the risk of recurrence, progression, or death by 60% compared to surgery alone, marking a major shift in the standard of care.
Amgen’s groundbreaking drug IMDELLTRA has secured full FDA approval for extensive stage SCLC based on compelling Phase 3 data. It reduced the risk of death by 40%, offering a major advance for relapsed patients.
European Commission has granted conditional approval for the subcutaneous version of Roche’s bispecific antibody, Lunsumio (mosunetuzumab). This new formulation for relapsed or refractory follicular lymphoma offers high rates of deep and durable responses while reducing treatment administration time from several hours to approximately one minute. This enhanced flexibility promises a better treatment experience for patients and streamlined care delivery in clinics.
