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AstraZeneca-Daiichi Sankyo’s Enhertu gets US FDA approval for breast cancer

Pharmaceutical Technology

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. months compared with 5.1 months for the chemotherapy arm. months compared with 16.8

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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

The company claimed that the utmost benefit is reported in hormone-receptor positive (HR+) women and those who commence treatment with Nerlynx within a year of receiving trastuzumab-based therapy. In a Phase III ExteNET clinical trial, neratinib offered a 34% decline in the risk of recurrence and a 2.3%

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US FDA approves expanded indication for Lilly’s breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for the expanded indication for Eli Lilly and Company ’s (Lilly) Verzenio (abemaciclib) to treat breast cancer patients. In the trial, Verzenio along with ET reduced disease recurrence risk by 35% compared to ET alone.

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Tamibarotene Fails in Phase III Trial for a Subset of Higher-Risk MDS

XTalks

Syros Pharmaceuticals announced that its cancer drug tamibarotene failed to meet its primary endpoint in the SELECT-MDS-1 Phase III trial. The placebo-controlled SELECT-MDS-1 trial involved 190 patients with complete response rate (CRR) being the study’s primary endpoint. percent and 18.8

Trials 105
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ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition

Pharmaceutical Technology

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. month OS benefit compared to SOC chemotherapy in the DESTINY-Breast04 trial. months) versus physicians’ choice chemotherapy (11.2

HR 162
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FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure

pharmaphorum

.” The FDA’s decision to expand the indications for Jardiance was based on results from the international, randomised, double-blind EMPEROR-Preserved phase III trial, which evaluated the safety and efficacy of Jardiance 10mg compared to placebo and standard of care therapy. absolute risk reduction, 0.79

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ASCO 2023: Keytruda becomes a new option in perioperative NSCLC  

Pharmaceutical Technology

in the placebo arm (hazard ratio [HR]: 0.58). months in the placebo arm (HR: 0.73). In March 2022, the FDA approved Bristol Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) for use in the neoadjuvant setting, giving it the first-to-market-advantage, based on results from the Phase III CHECKMATE-816 study.

HR 189