Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expre…

Recommendation based on results from the Phase 3 CheckMate -816 trial, in which Opdivo with chemotherapy demonstrated improved event-free survival and pathologic complete response compared to chemotherapy alone when administered before surgery If approved, Opdivo with chemotherapy would be the first and only neoadjuvant immunotherapy-based option authorized to treat patients with non-small cell…

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Source: news.bms.com

Categories: Hem/Oncs, Latest Headlines

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Aɴᴛᴏɴɪᴏ Pᴀssᴀʀᴏ

🆕No good news from @EMA_News for patients with resectable lung cancer! CM816 received positive CHMP opinion only for patients with PD-L1 ≥1%…!!! Again, and again…differing from @FDAOncology https://t.co/HtX1pm4Fsx https://t.co/0ebHNdooIc

CHMP Adopts Positive Opinion Recommending Approval of Bristol Myers Squibb’s Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Recommendation based on results from CheckMate -901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit versus standard-of-care chemotherapy alone…

tompowles April 26, 2024

CHMP Adopts Positive Opinion Recommending Approval of Bristol Myers Squibb’s Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

April 26, 2024

Antibody-drug conjugates in lung and breast cancer: Current evidence and future directions – a position statement from the ETOP IBCSG Partners Foundation

Following the approval of the first antibody-drug conjugates (ADCs) in the early 2000s, development has increased dramatically, with 14 ADCs now approved and >100 in…

Antonio Passaro, MD PhD April 24, 2024

Bristol Myers Squibb and Cellares Announce a $380M Worldwide Capacity Reservation and Supply Agreement for the Manufacture of CAR T Cell Therapies to Bring the Promise of Cell Therapy to More Patients, Faster

Bristol Myers Squibb will utilize Cellares’ proprietary Cell Shuttle, a next-generation end-to-end, fully automated cell therapy manufacturing platform, for the clinical and commercial-scale manufacturing of…

April 22, 2024

Antibody-drug conjugates in lung and breast cancer: Current evidence and future directions – a position statement from the ETOP IBCSG Partners Foundation

Following the approval of the first antibody-drug conjugates (ADCs) in the early 2000s, development has increased dramatically, with 14 ADCs now approved and >100 in…

Antonio Passaro, MD PhD April 22, 2024

KRAZATI (adagrasib) in Combination with Cetuximab Demonstrates Clinically Meaningful Activity as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)

Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted…

April 8, 2024

Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

KarXT demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment A majority of…

April 6, 2024

Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

Long-term treatment with KarXT was associated with continued improvements in symptoms of schizophrenia across all efficacy measures at 52 weeks More than 75% of participants…

April 6, 2024

U.S. FDA Approves Bristol Myers Squibb and 2seventy bio’s Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death…

Dr. Jeffrey Zonder April 6, 2024

U.S. FDA Approves Bristol Myers Squibb and 2seventy bio’s Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death…

Dr. Jeffrey Zonder April 5, 2024

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