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FDA grants approval to Gilead Sciences’ breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

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Novartis Piqray(R) – First and only treatment specially for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer receives HSA approval

Pharma Mirror

The post Novartis Piqray(R) – First and only treatment specially for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer receives HSA approval appeared first on Pharma Mirror Magazine. Novartis announced the Health Sciences Authority (HSA) has approved* Piqray®, an ?-specific

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Itovebi (Inavolisib) Gains FDA Nod for PIK3CA-Mutated HR-Positive, HER2-Negative Breast Cancer

XTalks

The US Food and Drug Administration (FDA) has approved Itovebi (inavolisib) for the treatment of adults with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation.

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

pharmaphorum

Along with data from its antibody-drug conjugates and oral selective oestrogen receptor degrader (SERD) camizestrant reported earlier, AZ presented results of the CAPItello trial of AKT inhibitor capivasertib in combination with injectable SERD Faslodex (fulvestrant) in hormone receptor positive, HER2-negative advanced breast cancer.

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

Pharmaceutical Technology

According to the trial data, Enhertu lowered disease progression or mortality risk by 50% compared with chemotherapy according to the physician’s choice in HER2-low metastatic breast cancer patients with hormone receptor (HR)-positive disease or HR-negative disease. months compared with 5.1 months for the chemotherapy arm.

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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%