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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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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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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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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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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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

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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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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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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The Pharma Data

FEBRUARY 8, 2021

With nearly four years of median follow-up, data from the final analysis of the Phase 3 TITAN study confirmed that ERLEADA ® plus ADT provided a statistically significant improvement in OS with a 35 percent reduction in risk of death versus ADT alone (HR 0.65; p<0.0001). About Metastatic Castration-Sensitive Prostate Cancer.

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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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HR Hormones Medicine Trials 52

XTalks

FEBRUARY 7, 2023

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

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HR Hormones FDA Approval Antibody 52

XTalks

NOVEMBER 20, 2023

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.

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XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

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Drug Discovery World

APRIL 11, 2024

In clonogenic assay, BRCA2-deficient DLD1 cells were ~15-fold more sensitive to FEN1 inhibition than their isogenic BRCA2-wild-type counterparts (EC50 of 350nM and 5µM, respectively), confirming the increased susceptibility of HR deficient cancer cells to FEN1 inhibition.

HR 52

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Pfizer

JANUARY 27, 2023

Breastfeeding individuals with COVID19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID19. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. No dosage adjustment is needed in patients with mild renal impairment.

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XTalks

AUGUST 10, 2022

Approximately 80 to 85 percent of these cases were previously considered to be the HER2-negative subtype (which includes hormone receptor positive and triple negative breast cancer), which means the tumors do not make higher than normal amounts of the HER2 protein. Enhertu Trial Data. Of the trial participants, females made up 99.6

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The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 The monarchE trial is ongoing and patients will continue to be followed to assess safety, PROs and other endpoints.

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The Pharma Data

AUGUST 30, 2021

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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Hormones HR Trials Protein 52

XTalks

FEBRUARY 5, 2024

PD-1 checkpoint inhibitors like Opdivo and Keytruda have been transformative in oncology, with Keytruda having had the edge due to having approvals in several more indications than Opdivo and strong clinical trial results, including as a first-line treatment in combination with chemotherapy. percent from 2021 to 2022 for Janssen.

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FDA Approval Drugs Sales Development 52

Drug Discovery World

JUNE 8, 2023

Ground-breaking data from several key cancer trials were announced at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Tagrisso reduced the risk of death by 51% compared to placebo in both the primary analysis population (Stages II-IIIA) and in the overall trial population (Stages IB-IIIA).

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Research Trials HR Hormones 52

pharmaphorum

SEPTEMBER 21, 2022

Takeda has decided that there is a future for its aurora kinase A inhibitor alisertib after it failed a phase 3 trial in lymphoma – but the company won’t be taking the drug forward itself. Takeda is also in line for just over $287 million in potential milestone payments, plus royalties on net sales if it reaches the market.

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Pfizer

DECEMBER 13, 2022

Breastfeeding individuals with COVID19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID19. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. No dosage adjustment is needed in patients with mild renal impairment.

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Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives.

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The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; months: HR 0.70 [95% CI, 0.60-0.83]). months: HR 0.70 [95% CI, 0.60-0.83]). 0.83]; p<0.0001).

HR 52

HR In-Vitro Development Clinical Trials 52

Pfizer

NOVEMBER 23, 2022

19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID?19. Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Pediatrics: PAXLOVID is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg.

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Licensing Licensing Drugs Manufacturing 40

Pharmaceutical Technology

MARCH 2, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It was also under development for the treatment of nasopharyngeal cancer and homologous-recombination deficient (HRD) metastatic hormone refractory prostate cancer.

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XTalks

AUGUST 2, 2023

5) Ibrance (palbociclib) Ibrance is a chemotherapy drug indicated for hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. It is a CDK 4/6 inhibitor that is taken in combination with other hormonal therapies to stop the growth of cancer and healthy cells.

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Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

APRIL 14, 2021

The FDA’s accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint. Continued approval is contingent upon verification and description of clinical benefit in a confirmatory trial. About Trodelvy.

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Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

JUNE 18, 2021

The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. vs. 11.4%) (p < 0.0001).

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

JUNE 18, 2021

lead study investigator of the Phase 3 RESONATE-2 trial, and Professor of Medicine at the Wilmot Cancer Institute, University of Rochester. “The results add to the extensive clinical evidence supporting the use of single-agent ibrutinib for long-term disease control.” Isolated growth hormone deficiency. ? Barr , M.D.,

FDA Approval 40

FDA Approval Medicine Development Trials 40

The Pharma Data

MAY 4, 2021

The findings represent the first comprehensive comparative effectiveness analysis of survival outcomes for a CDK 4/6 inhibitor in routine clinical practice and were published online in Breast Cancer Research. Results from the study are expected to be available in the second half of 2021. A decision from the EC is expected in 2022.

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