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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.
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
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.
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.
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.
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.
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%
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. Findings of the study, reported at the ESMO Congress 2022, demonstrated a 3.2-month
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 (..)
Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Among premenopausal women with hormone receptor (HR)-positive, early-stage breast cancer enrolled in the SOFT trial, those with a high score on a genomic assay called Breast Cancer Index (BCI) had increased risk of distant recurrence, and those with low BCI benefited more from the addition of ovarian suppression therapy to endocrine therapy after 12 (..)
Novartis announced this week that the FDA has approved ribociclib (marketed as Kisqali) for the treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR-positive, HER2-negative) stage two or three early breast cancer, who are at high risk of cancer recurrence.
The 'life-extending' drug combination is recommended for usage in adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer who have previously received hormone therapy.
Credit: SWOG/The Hope Foundation In an analysis of data from postmenopausal patients with hormone receptor-positive breast cancer, a standard measure of gene expression known as the sensitivity-to-endocrine-therapy (SET2,3) index was found to have prognostic value that complemented the known prognostic value of the 21-gene breast recurrence score.
Verzenio along with endocrine therapy (ET) has received approval as an adjuvant treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) adult patients who are at a high recurrence risk.
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).
Data from latest research presented at the ESMO Virtual Congress 2020 Lugano, Switzerland, 20 September 2020 – Adding abemaciclib to hormonal therapy reduces the risk of cancer recurrence by 25% in patients with high-risk early hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer, according to (..)
AstraZeneca noted that the sBLA is based on findings from the randomised, open-label Phase III DESTINY-Breast04 clinical trial of Enhertu in priorly treated subjects with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease.
New data has been unveiled for the combination of Novartis’ Piqray (alpelisib) with AstraZeneca’s Faslodex (fulvestrant) in the treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer in patients whose tumours are PIK3CA positive. months compared to 14.8
Non-Hispanic Black women with hormone receptor (HR)-positive/HER2-negative, lymph node-positive breast cancer had worse outcomes compared to non-Hispanic whites, Asians, and Hispanics, despite similar 21-gene recurrence scores, according to a study presented at the 2022 San Antonio Breast Cancer Symposium, held December 6-10, 2022.
Nasdaq: GILD) today announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy ® (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. Gilead Sciences, Inc.
20-year research breakthrough offers new hope for high risk patients with HR+ breast cancer A new treatment for breast cancer patients with hormone receptor (HR+) early stage disease who are at a high risk of recurrence has been shown to reduce the risk by 25%, according to a study led by The Royal Marsden NHS […].
Lugano, Switzerland, 19 September 2021 – Adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal women with hormone receptor (HR) positive, HER2 negative advanced breast cancer, according to late breaking results of the MONALEESA-2 trial presented at the ESMO Congress 2021. (1)
At this year’s ASCO congress, the Trop2-targeting antibody-drug conjugate (ADC) was found to improve progression-free survival significantly in in patients with hormone receptor-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment.
months with letrozole alone (HR 0.58: 95% CI, 0.49 months among patients in the letrozole group (HR 0.66: 95% CI, 0.53 This real-world cohort includes more than 1,400 women with HR+, HER2- mBC with any extent of visceral disease. months with IBRANCE plus letrozole versus 11.9 to 0.82; P=0.0002). in the IBRANCE group and 68.0%
A study led by researchers from The University of Texas MD Anderson Cancer Center showed a significant overall survival benefit with ribociclib plus endocrine therapy for postmenopausal patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer.
The two partners say new data from the phase 1 TROPION-PanTumor01 of TROP2-targeting datopotamab deruxtecan showed “encouraging and durable efficacy” when used to treat patients with hormone receptor (HR)-positive, HER2-low, or HER2-negative metastatic breast cancer who have been treated with multiple earlier therapies.
NASDAQ: PBYI), a biopharmaceutical company, announced that efficacy results of neratinib in HER2-positive, hormone receptor-positive (HR+), early stage breast cancer (eBC) from the Phase III ExteNET trial were … Continue reading →
AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. billion to $1.28
The phase 2 AMEERA-3 trial was testing amcenestrant in women aged 18 and over with hormone receptor-positive, HER2-negative advanced breast cancer, and showed no benefit in progression-free survival for the drug compared to physician’s choice endocrine therapy.
The Swiss pharma said in its update that the acelERA trial comparing giredestrant to physician’s choice of endocrine therapy for previously-treated hormone receptor (HR)-positive, HER2-negative breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).
When added to standard treatment with hormone-based drugs, Ibrance (palbociclib) was unable to achieve better iDFS than hormone therapy alone in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early-stage breast cancer.
1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. 4 Currently, chemotherapy remains the only treatment option both for patients with HR-positive tumours following progression on endocrine (hormone) therapy, and for those who are HR-negative.5.
HR+/HER2- breast cancer is the most common type of breast cancer, with the National Cancer Institute (NCI) estimating 287,850 new cases of female breast cancer in 2022 alone. Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options. months vs. 11.2
1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease. 6 Currently chemotherapy remains the only treatment option for patients with HR-positive tumours following progression on endocrine (hormone) therapy. 7 Few targeted options are available for those who are HR-negative.
Overall, 75 and 87 percent of Black and White patients, respectively, had hormone receptor-positive (HR+) tumors. No intergroup differences were seen for women with HR+/human epidermal growth factor receptor 2-negative tumors regarding type of surgery, chemotherapy regimen, radiation, or endocrine treatment.
Prospects for Gilead Sciences’ Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer continue to improve as data from the TROPiCs-02 trial strengthen, but the jury is still out on what that might mean for the drug commercially.
Results from the SERENA-2 study have shown that camizestrant met its primary objective of improving progression-free survival (PFS) compared to Faslodex (fulvestrant) in patients with hormone receptor-positive advanced breast cancer previously treated with endocrine therapy.
In Europe, approximately 531,000 breast cancer patients are diagnosed annually, with around 141,000 deaths, and around half of all cases would fall under the HER2-low classification, split between patients with both hormone receptor (HR) positive and HR negative disease.
The trial evaluated Trodelvy (sacituzumab govitecan) in patients with HR-positive, HER2-negative metastatic breast cancer who received multiple lines of prior treatment, and showed that the drug extended progression-free survival to 5.5 At ASCO the numbers have been revealed, and the picture isn’t much clearer.
Gilead Sciences will hear back from the FDA in February next year about its marketing application for Trodelvy in hormone receptor-positive, HER2-negative metastatic breast cancer, billed by the drugmaker as a key new indication for the drug.
It was comparing the drug to letrozole – both given on top of Pfizer’s Ibrance (palbociclib) – as first-line therapy for patients with HR-positive/HER2-negative advanced breast cancer.
KEYTRUDA Now Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer. KEYTRUDA Approved for the Treatment of Patients With PD-L1-Positive, Hormone Receptor-Negative and HER2-Negative, Inoperable or Recurrent Breast Cancer. months (95% CI, 7.6-11.3)
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