Pharmaceutical Technology

MARCH 6, 2023

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.

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FDA Approval HR Hormones Clinical Trials 130

Scienmag

SEPTEMBER 20, 2020

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 (..)

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HR Hormones Drugs Research 45

BioTech 365

OCTOBER 5, 2020

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 →

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Hormones HR Trials 52

The Pharma Data

SEPTEMBER 21, 2020

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.

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HR Hormones Trials 52

pharmaphorum

APRIL 25, 2022

Roche revealed in its first-quarter results statement that giredestrant missed the mark in the phase 2 acelERA trial in advanced breast cancer, in what appears to be another blow to the emerging oral selective oestrogen receptor degrader (SERD) class.

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Trials Hormones HR Sales 69

Scienmag

SEPTEMBER 19, 2021

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)

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HR Hormones Trials 52

pharmaphorum

MARCH 14, 2022

Shares in Sanofi were on the slide this morning after the drugmaker revealed that one of its top pipeline prospects – selective oestrogen receptor degrader (SERD) amcenestrant – stumbled in a mid-stage breast cancer trial. The post Sanofi takes a hit as hotly tipped breast cancer drug fails trial appeared first on.

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Pharmaceutical Technology

JULY 25, 2022

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.

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HR Hormones Clinical Trials Clinical Trials 130

The Pharma Data

FEBRUARY 21, 2022

All patients in the trial received a HER2 test, and the results were centrally confirmed. 1,2 HER2-low expression occurs in both HR-positive and HR-negative disease.3. The trial met the key secondary endpoint of PFS in patients with HER2-low metastatic breast cancer regardless of HR status (HR-positive or HR-negative).

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The Pharma Data

MARCH 25, 2021

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 Real-world evidence is woven into the fabric of how we innovate and advance care for patients with breast cancer, supporting our randomized clinical trials,” said Chris Boshoff, M.D., to 0.82; P=0.0002).

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HR Clinical Trials Clinical Trials Trials 52

pharmaphorum

OCTOBER 11, 2020

Pfizer already makes big revenues from its breast cancer drug Ibrance, but a late-stage trial failure has set back its hopes of even loftier sales – and set up a challenge from Eli Lilly’s rival drug Verzenio. That study isn’t due to read out until 2026, according to the ClinicalTrials.gov database.

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Trials HR Hormones Drugs 52

The Pharma Data

MARCH 27, 2023

The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met. “There is a critical need for new, well-tolerated options that keep patients cancer-free without disrupting quality of life.

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pharmaphorum

AUGUST 17, 2022

Sanofi has called time on breast cancer candidate amcenestrant – at one time one of its top pipeline prospects – after it missed the mark in another clinical trial. The post End of the line for Sanofi’s SERD amcenestrant as it fails first-line trial appeared first on.

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Trials HR Hormones Development 52

Drug Discovery World

DECEMBER 14, 2023

Antibody drug conjugate MBRC-101 MBrace Therapeutics presented preclinical data demonstrating the potential of its novel antibody drug conjugate MBRC-101 for the treatment of solid tumours including hormone receptor-positive (HR+) and triple negative breast cancers. months in heavily pre-treated patients. “We

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HR Hormones Trials In-Vivo 52

Drug Discovery World

JUNE 7, 2023

Positive primary endpoint data from Novartis’ pivotal Phase III NATALEE trial has been presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

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HR Drugs Hormones Trials 52

pharmaphorum

AUGUST 15, 2022

In the space of a couple of months, Gilead Sciences’ Trodelvy impact on overall survival (OS) in the TROPICs-02 trial in advanced breast cancer has gone from a trend to a statistically significant improvement, raising its chances of approval in a new indication.

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Scienmag

SEPTEMBER 29, 2020

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 […].

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HR Hormones Research Clinical Trials 61

The Pharma Data

APRIL 27, 2022

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.

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HR Trials Protein Medicine 52

pharmaphorum

OCTOBER 26, 2022

AstraZeneca seems to have dodged the problems besetting other developers of oral selective oestrogen receptor degrader (SERD) drugs with a phase 2 win for its candidate camizestrant in a phase 2 trial. It’s worth noting that the trial has a different design to those conducted by Sanofi and Roche. Capivasertib trial also positive.

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HR Trials Drugs Hormones 52

pharmaphorum

SEPTEMBER 9, 2022

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.

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HR Hormones Trials Sales 52

The Pharma Data

JUNE 2, 2023

That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. chief medical officer, Loxo@Lilly. chief medical officer, Loxo@Lilly. Source link: [link]

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The Pharma Data

JUNE 2, 2023

This approval was based on an exploratory subgroup analysis of the Phase 3 PROpel trial which showed that LYNPARZAplus abi/pred demonstrated clinically meaningful improvements in both radiographic progression-free survival (rPFS) (HR=0.24 [95% CI, 0.12-0.45]) 0.45]) and overall survival (OS) (HR=0.30 [95% CI, 0.15-0.59])

FDA Approval 52

FDA Approval HR Trials Hormones 52

pharmaphorum

OCTOBER 12, 2022

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.

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HR Sales Hormones Antibody 52

pharmaphorum

SEPTEMBER 17, 2021

The Swiss drugmaker presented results from its coopERA trial of giredestrant in post-menopausal women with hormone receptor (HR)-positive, HER2-negative early breast cancer at the ESMO congress today which suggest its programme is on track.

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HR Hormones Trials Sales 52

pharmaphorum

SEPTEMBER 23, 2022

The cost-effectiveness agency has said that Ibrance (palbociclib) plus fulvestrant can be used routinely on the NHS as a second-line therapy for patients with advanced hormone receptor-positive, HER2-negative breast cancer who have already been treated with hormonal drugs. months in the trial, median overall survival was 6.8

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Hormones HR Medicine Drugs 52

Drug Discovery World

JUNE 1, 2023

Trials and approvals The more successful trials that researchers complete, the more scope there is for improvement and approvals and the more drugs that are approved for use, the more research can be done.

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The Pharma Data

AUGUST 30, 2021

New Kisqali ® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2? Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177 Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. 19, 2:10 PM CEST].

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The Pharma Data

JULY 22, 2021

ARV-471 is currently in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor (ER) positive / human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic breast cancer. “We The estrogen receptor is a well-known disease driver in most breast cancers.

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Protein Development HR Hormones 52

The Pharma Data

JUNE 19, 2023

The findings bolster the idea, which is currently under investigation in at least three clinical trials, that when it comes to treating resistant breast cancer, two drugs may be better than one.

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Drugs HR Scientist Hormones 40

The Pharma Data

OCTOBER 23, 2021

The blessing is grounded on final analysis from the Phase 3 KEYNOTE-355 trial, in which KEYTRUDA in combination with chemotherapy ( nab-paclitaxel, paclitaxel or gemcitabine/ carboplatin) significantly bettered overall survival ( Zilches), reducing the threat of death by 27 (HR = 0.73 (95 CI,0.55-0.95);

HR 52

HR Hormones Trials Vaccination 52

Drug Discovery World

APRIL 4, 2023

Read more: FDA clears in vivo gene editing therapy for trials in US RRx-001, EpicentRx Most recently, the FDA granted Fast Track Designation to RRx-001 for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients.

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FDA Approval In-Vivo Gene Editing Drugs 52

Drug Discovery World

JANUARY 9, 2024

The therapy has shown positive results in Phase III trials in both breast and lung cancer. Niraparib + abiraterone acetate (Akeega), Johnson & Johnson This is the first and only dual action tablet combining a PARP inhibitor (niraparib) and a next-generation hormonal therapy (abiraterone acetate).

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Drugs Gene Editing Antibody Medicine 69

The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme.

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HR Medicine Hormones Trials 52

The Pharma Data

SEPTEMBER 6, 2021

Over 70% of breast cancer cases are hormone receptor (HR)-positive, and there is a need for more effective and tolerable treatments, since up to 30% of patients develop resistance to standard of care treatments and in the adjuvant setting half of patients stop treatment due to the toll of side effects. Real world data. Lung cancer.

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Genome Genomics HR Hormones 52

The Pharma Data

DECEMBER 2, 2020

Abemaciclib is a cyclin dependent kinase (CDK) 4 & 6 inhibitor used in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. . PLYMOUTH MEETING, Pa. ,

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Pharmaceutical Technology

SEPTEMBER 13, 2022

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.

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HR Marketing Hormones FDA Approval 162

The Pharma Data

MARCH 7, 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. Its safety and efficacy have not been established for this indication.

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