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Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

The regulatory approval was based on the data obtained from the DESTINY-Breast04 Phase III trial, which was conducted in HR-positive or HR-negative, HER2-low unresectable or metastatic breast cancer patients, who have received one or two prior lines of chemotherapy.

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SABCS: Pharmas show their working in HR+/HER2- breast cancer

pharmaphorum

The San Antonio Breast Cancer Symposium (SABCS) has highlighted some of the most promising clinical research being undertaken by drugmakers in the category, with AstraZeneca leading the charge with a trio of major trial readouts. The post SABCS: Pharmas show their working in HR+/HER2- breast cancer appeared first on.

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Pfizer seeks approval from US FDA for Covid-19 treatment

Pharmaceutical Technology

The latest filing is based on non-clinical and clinical data for Paxlovid and also comprised data from the Phase II/III EPIC-HR clinical trial. Furthermore, findings from the final trial report showed a relative risk decline of 86%.

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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

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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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EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Pharmaceutical Technology

It is also based on the data obtained from the DESTINY-Breast04 Phase III trial, which assessed Enhertu’s safety and efficacy against the physician’s choice of chemotherapy. The European Commission’s approval comes after the positive opinion of the Committee for Medicinal Products for Human Use.

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