Health and Pharma

11/20/2025

has approved -bysp ( ) with and for relapsed or refractory and has also granted full approval to the agent as monotherapy after two or more prior therapies. This decision, supported by the Phase 3 EPCORE FL 1 trial, establishes the regimen as the first combination in this setting and demonstrates a 79 percent reduction in the risk of progression or death, along with high complete response rates and a manageable safety profile.
https://healthandpharma.net/fda-epcoritamab-bysp-epkinly-follicular-lymphoma

11/18/2025

has approved ( ) the first oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid ( ). In the KOMET-001 trial, the therapy achieved a 21.4 percent rate of complete remission and a median response duration of five months, with manageable toxicity and the convenience of once-daily oral administration.
https://healthandpharma.net/fda-approves-ziftomenib-npm1-aml-acute-myeloid-leukemia

The FDA has approved ziftomenib (KOMZIFTI), the first oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia (AML). In the KOMET-001 trial, the therapy achieved a 21.4 percent rate of complete remission with manageable toxicity.

11/15/2025

Results from the Phase III trial show that adding the therapy (177Lu-PSMA-617) to androgen deprivation therapy and an ARPI reduced the risk of disease progression or death by 28% in + metastatic hormone-sensitive ( ). The combination also delayed castration resistance and showed a favorable safety profile with manageable toxicity.
https://healthandpharma.net/psmaddition-radioligand-therapy-pluvicto-prostate-cancer

11/13/2025

New data from the phase -303 study show that adding the DLL3-targeted bispecific T-cell engager ( ) to first-line achieved a 71% response rate and 10.3-month median PFS in extensive-stage small-cell ( ), with manageable cytokine-related toxicity and a median overall survival of 25.3 months in the maintenance cohort.

New data from the phase 1b DeLLphi-303 study show that adding tarlatamab to first-line chemoimmunotherapy achieved a 71% response rate and 10.3-month median PFS in extensive-stage small-cell lung cancer

11/13/2025

Five-year data from the Phase III confirm that adjuvant ( ) plus endocrine therapy reduces recurrence risk by 28% in patients with HR+/HER2– early . The regimen achieved 85.5% five-year invasive disease-free survival versus 81% with alone, with durable benefit beyond treatment completion, and no new safety signals.

Five-year data from the Phase III NATALEE trial confirm that adjuvant ribociclib (Kisqali) plus endocrine therapy reduces recurrence risk by 28% in patients with HR+/HER2– early breast cancer. The regimen achieved 85.5% five-year invasive disease-free survival versus 81% with endocrine therapy alo...

11/13/2025

Results from the phase II trial show that plus significantly prolonged progression-free survival to 15.7 months versus 10.2 months with cabozantinib in patients with metastatic clear cell renal cell carcinoma ( ) progressing after PD-1 . The combination achieved a 52.6% response rate but required careful toxicity management.

Results from the phase II LenCabo trial show that lenvatinib plus everolimus significantly prolonged progression-free survival to 15.7 months versus 10.2 months with cabozantinib in patients with metastatic clear cell renal cell carcinoma progressing after PD-1 immunotherapy.

11/12/2025

Novartis has opened a new therapy (RLT) manufacturing facility in California, as part of its $23 billion US expansion. The site, Novartis’ third plant in the country, will supply patients across the western US, reinforcing the company’s 99.9% on-time delivery record and leadership in precision for advanced .
https://healthandpharma.net/novartis-invests-23-billion-radioligand-manufacturing-carlsbad

11/08/2025

Findings from the DYNAMIC-III trial, show that circulating DNA ( ) testing can transform post-surgical care in . Among more than 1,000 patients, ctDNA-negative individuals achieved 87% three-year recurrence-free survival with reduced , while ctDNA-positive patients faced a 50% recurrence risk despite intensified therapy, as escalated treatment did not improve outcomes and higher ctDNA burden correlated with poorer recurrence-free survival.

Findings from the DYNAMIC-III trial, show that circulating tumor DNA (ctDNA) testing can transform post-surgical care in Stage III colon cancer. Among more than 1,000 patients, ctDNA-negative individuals achieved 87% three-year recurrence-free survival with reduced chemotherapy,

11/06/2025

Findings from the Phase 3 ASCENT-03 trial, presented at ESMO 2025, demonstrated that govitecan ( ) significantly reduced the risk of disease progression or death by 38% compared with in untreated metastatic triple-negative patients ineligible for PD-1/PD-L1 inhibitors. Median progression-free survival was 9.7 versus 6.9 months, establishing Trodelvy as a potential new first-line standard for this hard-to-treat population.
https://healthandpharma.net/trodelvy-mtn-breast-cancer-sacituzumab-govitecan-gilead

11/06/2025

ESMO’s new guidance, published in Annals of , distills 23 consensus statements from 20 experts to safely integrate -LLMs into care. It categorizes as patient-facing, clinician-facing, or background systems, requiring human oversight, local validation, privacy-by-design, and continuous monitoring.
https://healthandpharma.net/esmo-ai-llm-guide-roadmap-oncology-cancer-care

11/04/2025

Results from the phase 3 TROPION-Breast02 trial, presented at the ESMO 2025 Congress, show that ® ( ) significantly extended overall survival (OS) by five months and nearly doubled progression-free survival (PFS) versus in patients with metastatic triple-negative ineligible for .

Results from the phase 3 TROPION-Breast02 trial, presented at the ESMO 2025, show that Datroway® (datopotamab deruxtecan) significantly extended overall survival by five months versus chemotherapy in patients with metastatic triple-negative breast cancer ineligible for immunotherapy.

10/21/2025

An -driven study of 3,476 patients, presented at , reveals that thymic health is strongly linked to success. Patients with higher scores had a 35% lower risk of disease progression and a 44% lower risk of death, highlighting as a powerful, non-invasive for predicting immune response across cancers, including NSCLC, , renal, and .
https://healthandpharma.net/esmo25-ai-thymic-health-immunotherapy-cancer