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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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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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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.

HR 162
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Adding capivasertib to fulvestrant improves progression-free survival of hormone receptor-positive breast cancer

Medical Xpress

In patients with hormone receptor (HR)-positive, HER2-negative tumors resistant to aromatase inhibitors, addition of the investigational AKT inhibitor capivasertib to fulvestrant (Faslodex) doubled the median progression-free survival compared with placebo plus fulvestrant in the phase III CAPItello-291 clinical trial, according to results presented (..)

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Novartis touts breast cancer win with “landmark” Kisqali results

Pharmaceutical Technology

Data from Novartis ’ Phase III NATALEE trial show that adding Kisqali to endocrine therapy lowered the risk of cancer recurrence by 25% in patients with hormone receptor-positive (HR+)/HER2- early-stage breast cancer (EBC).

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