FDA Approves Bristol-Myers Squibb’s Empliciti Combo
Bristol-Myers Squibb Company announced that the FDA approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 In Eloquent-3, a randomized, open-label, Phase 2 trial, EPd demonstrated benefit in patients with…
Bristol-Myers Squibb and Infinity Pharmaceuticals to Evaluate Opdivo in Combination with IPI-549 in Urothelial Cancer
Bristol-Myers Squibb Company and Infinity Pharmaceuticals announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with Infinity’s IPI-549 in patients with advanced urothelial cancer. IPI-549 is an oral immuno-oncology development candidate that is designed to selectively inhibit phosphoinositide-3-kinase (PI3K)-gamma and is the only investigational PI3K-gamma inhibitor in clinical development. Infinity will operationalize MARIO-275: MAcrophage Reprogramming in Immuno-Oncology,…
Bristol-Myers Squibb Reports Positive Mid-Stage Data for TYK2 Inhibitor in Plaque Psoriasis
Bristol-Myers Squibb announced results from a Phase 2 study of BMS-986165, an investigational oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. Efficacy endpoints including ≥75 percent and 90 percent reduction in the Psoriasis Area and Severity Index (PASI 75, PASI 90) were achieved following 12 weeks of treatment with ≥3…
FDA Accepts Bristol-Myers Squibb’s Application for Sprycel
Bristol-Myers Squibb Company announced that the FDA accepted its supplemental Biologics License Application (sBLA) for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). The FDA action date is December 29, 2018. “Sprycel was first established as an important treatment option for appropriate pediatric patients last…
Opdivo Approved by FDA for Small Cell Lung Cancer
Bristol-Myers Squibb announced that Opdivo (nivolumab) received approval from the FDA as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.1 Approval for this indication has been granted under accelerated approval based on overall response rate (ORR)…
Bristol-Myers Squibb 2Q Results Boosted By Eliquis and Opdivo Sales
Bristol-Myers Squibb Company‘s second quarter of 2018 results were boosted by strong sales for Eliquis (apixaban) and Opdivo (nivolumab), and significant regulatory progress in the company’s immuno-oncology portfolio. Second Quarter $ amounts in millions, except per share amounts 2018 2017 Change Total…
China National Drug Administration Approves Country’s First Immuno-Oncology Agent
The China National Drug Administration (CNDA) has approved Bristol-Myers Squibb’s Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations. This is China’s first and only PD-1 inhibitor and is the only Immuno-Oncology (I-O) agent to demonstrate a…
Bristol-Myers Squibb Receives Positive European Agency Opinion
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of an every four-week (Q4W) Opdivo (nivolumab) dosing schedule of 480 mg infused over 60 minutes as an option for patients with advanced melanoma and previously treated renal cell carcinoma. The CHMP also recommended approval of a two-week (Q2W) Opdivo dosing option…
Bristol-Myers Squibb Drug Combo Tops Chemo In Phase 3 Trial
Pivotal Phase 3 CheckMate -227 study demonstrates superior progression-free survival with the Opdivo plus Yervoy combination versus chemotherapy in first-line non-small cell lung cancer patients with high tumor mutation burden. Bristol-Myers Squibb Company announced that the ongoing Phase 3 CheckMate -227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo (nivolumab) plus…
Strong Sales For Opdivo And Eliquis Boost Bristol-Myers Squibb Results
Bristol-Myers Squibb Company reported results for the fourth quarter and full year of 2017, which were highlighted by strong sales for Opdivo and Eliquis along with regulatory and clinical progress in oncology for Opdivo and the Opdivo plus Yervoy combination. “I am proud of our results in 2017, with sales growth driven by strong commercial performance of our prioritized brands and important scientific advances we are…
Taris And Bristol-Myers Squibb Announce Clinical Trial Collaboration
Taris Biomedical LLC, and Bristol-Myers Squibb have entered into a clinical trial collaboration to evaluate the safety, tolerability, and preliminary efficacy of Taris’ investigational product, TAR-200 (GemRIS), in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo (nivolumab). The Phase 1b trial will evaluate the combination in patients with Muscle Invasive Bladder Cancer (MIBC) who are scheduled…
FDA Expands Approval Of Bristol-Myers Squibb Myeloid Leukemia Treatment
U.S. Food and Drug Administration expands approval of Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in…
Bristol-Myers Squibb Completes Acquisition of IFM Therapeutics
Bristol-Myers Squibb to Acquire IFM Therapeutics in $300M Upfront Deal
Sales of Opdivo and Eliquis Help Boost Bristol-Myers Squibb 2Q Results
Opdivo and Eliquis Help Boost Bristol-Myers Squibb Earnings
Bristol-Myers Squibb Company today reported results for the first quarter of 2017, which were highlighted by strong sales for key products Opdivo and Eliquis, regulatory approval for Opdivo in advanced bladder cancer in the U.S., positive opinions from the Committee for Medicinal Products for Human Use (CHMP) for advanced bladder and head and neck cancers in Europe, and strategic transactions in…
Bristol-Myers Squibb Collaborating on Opdivo-Antibody Combo in Cancer Fight
Bristol-Myers Squibb Melanoma Drug Produces Positive Test Data
Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo monotherapy significantly improved overall survival versus Yervoy alone in patients with previously untreated advanced melanoma. Bristol-Myers Squibb Company today announced the first overall survival (OS) data from the Phase 3 CheckMate -067 clinical trial. With a minimum follow-up of 28 months, the median OS had not yet…
Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo
Bristol-Myers Squibb and CytomX Extend Collaboration on Probody Therapeutics
Bristol-Myers/Pfizer: Direct Oral Anticoagulants Beat Warfarin for Some Patients
Bristol-Myers’ Opdivo Approved for Advanced Bladder Cancer Cases
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) in previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration (FDA) has approved Opdivo injection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during…
