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Investegate |Sanofi Announcements | Sanofi: Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting

  Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are

Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting

Sanofi to showcase data from its transformative oncology pipeline at 2021 ASCO Meeting oncology pipeline at 2021 ASCO Meeting Early clinical data for investigational oral selective estrogen receptor (SERD), amcenestrant, show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer Data that reinforce Libtayo (cemiplimab-rwlc) as a standard of care in advanced non-melanoma skin cancer and advanced non-small cell lung cancer, including new data in historically underrepresented patients with brain metastases Longer term data and new analyses for Sarclisa (isatuximab-irfc) further strengthen efficacy profile, including for elderly patients and patients with high-risk cytogenetic abnormalities PARIS , 20 21 - New research being presented at the upcoming virtual American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8 highlights Sanofi s transformative science and commitment to patient care across difficult-to-treat cancers, including mu

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma
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European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple

Press release content from Globe Newswire. The AP news staff was not involved in its creation. European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple . SanofiApril 19, 2021 GMT European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma Approval based on Phase 3 IKEMA study demonstrating Sarclisa added to standard of care carfilzomib and dexamethasone reduced risk of disease progression or death by 47% in patients who had relapsed after one to three prior therapies Sarclisa combination therapy was associated with undetectable levels of multiple myeloma (MM) in nearly 30% of patients with relapsed MM Second EU approval in less than 12 months for Sarclisa in combination with a standard of care regimen for the treatment of relapsed or refractory MM

European Commission approves second indication of Sarclisa® (isatuximab) for relapsed multiple myeloma

d the risk of progression or death by nearly half formed the basis for this important EC approval. Sarclisa Efficacy and Safety Profile in Difficult-to-Treat Patients This approval is based on data from the Phase 3 IKEMA study, a randomized, multi-center, open label clinical trial that enrolled 302 patients with relapsed MM across 69 centers spanning 16 countries. The primary endpoint of IKEMA was progression free survival (PFS). While median PFS, defined as time to disease progression or death, for Kd was 19.15 months, the median PFS for patients receiving Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination therapy; n=179) had not been reached at the time of the pre-planned interim analysis. Sarclisa combination therapy reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007) versus standard of care Kd alone in patients with MM.

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