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.
NEW BRUNSWICK, N.J., November 17, 2025 — Johnson & Johnson (NYSE: JNJ) said today that it has reached a final deal to pay $3.05 billion [Read More…]
Roche announced today that its investigational oral medication, fenebrutinib, has met primary endpoints in two separate, pivotal Phase III studies for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The drug significantly reduced relapse rates in RMS and slowed disability progression in PPMS, positioning it as a potential first-in-class, high-efficacy oral treatment for the two most common forms of the disease.
Gilead Sciences announced its Phase 3 ASCENT-07 trial for Trodelvy® in first-line HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of progression-free survival (PFS). However, the company reported an “early trend” favoring Trodelvy for the key secondary endpoint of overall survival (OS), and the study will continue to gather more data on this measure.
The FDA has approved GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma. The decision, backed by the pivotal DREAMM-7 trial, introduces a new, accessible anti-BCMA treatment that significantly improved overall survival and progression-free survival compared to the standard of care. This milestone offers renewed hope for patients who have relapsed after at least two prior lines of therapy.
Results from the ASCENT-03 study reveal that Trodelvy (sacituzumab govitecan-hziy) significantly enhances outcomes for patients with metastatic triple-negative breast cancer. The drug lowered the risk of disease progression or death by 38% and provided a longer duration of response compared to chemotherapy. This positions Trodelvy as a potential new standard of care for this aggressive form of breast cancer, offering hope to a patient population with limited treatment options.
