Anastrozole

Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

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星期三, 三月 20, 2024
Research, General Health, Pharmaceutical, Oncology, Public Relations, Investor Relations, Clinical Trials, Science, Biotechnology, Communications, Practice Management, Other Science, Health, Fulvestrant, Carcinoma, Progression-free survival, Patient, JAMA Oncology, Pharming, Biomarker, CDK, Letrozole, IND, Triple-negative breast cancer, Puma Biotechnology, Cancer, Paclitaxel, Breast cancer, Anastrozole, Tamoxifen, FDA, Food, Pharmaceutical industry

This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.

Key Points: 
  • This trial will investigate alisertib in combination with endocrine treatment (consisting of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen) in chemotherapy-naïve patients with hormone receptor-positive, HER2-negative recurrent or metastatic breast cancer.
  • Puma plans to initiate this trial in the second half of 2024.
  • Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial.
  • We look forward to the initiation of the ALISCA-Breast1 trial in the second half of 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

Verastem Oncology Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

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星期三, 十二月 13, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, NDA, Paclitaxel, Woman, Institute of Cancer Research, Research, Safety, Food, Avutometinib, Cancer, Letrozole, Disease, Verastem Oncology, Patient, Anastrozole, GOG, PFS, Consultant, RAMP, Breakthrough therapy, Part, FDA, NHS foundation trust, FRAME, ORR, The Institute, Ovarian cancer, FRCP, Doctor of Philosophy, Physician, Accelerated approval (FDA), Royal Marsden Hospital, Pharmaceutical industry, MBBS, Topotecan

“Patients and treating physicians have advocated for more research and development in support of LGSOC.

Key Points: 
  • “Patients and treating physicians have advocated for more research and development in support of LGSOC.
  • At Verastem Oncology, we are moving with urgency to offer a Phase 3 study specifically directed at this disease in an effort to address this need,” said Dan Paterson, President and Chief Executive Officer, Verastem Oncology.
  • RAMP 301 is a global trial with enrollment open in the U.S. and planned enrollment in Canada, the United Kingdom, Europe, Australia, and Korea.
  • Dr. Grisham and Dr. Banerjee are paid consultants for Verastem Oncology.

Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

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星期一, 十二月 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Paclitaxel, Tamoxifen, CDK, Food, Letrozole, Carcinoma, Fulvestrant, Progression-free survival, Doctor of Pharmacy, Breast cancer, Patient, Anastrozole, PFS, BID, FDA, Puma Biotechnology, DOR, DCR, ORR, PUMA, Phase, Biomarker, Cancer, Pharmaceutical industry, Birth control

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).
  • The Company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers.
  • “There continues to be a need for new drugs for the treatment of metastatic HER2-negative, hormone receptor-positive breast cancer,” said Alvin Wong, PharmD, Chief Scientific Officer of Puma Biotechnology.
  • “The clinical trials of alisertib to date in HER2-negative, hormone receptor-positive metastatic breast cancer have demonstrated alisertib’s potential clinical benefit in this patient population, and we look forward to initiating the PUMA-ALI-1201 trial in 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

Menarini Group Presents New Progression-Free Survival Data from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Clinically Relevant Subgroups of Patients with ER+, HER2- Metastatic Breast Cancer (mBC) with ESR1 Mutations at SABCS 2023

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星期五, 十二月 8, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Medicine, DSM-IV codes, Vomiting, Woman, Safety, CDK, Potassium, Therapy, Letrozole, Progression-free survival, Back pain, Fulvestrant, Abdominal pain, Doctor of Science, Headache, Risk, Liver, Disease, Cholesterol, PIK3CA, Constipation, Fatigue, Indigestion, Anastrozole, Patient, Multimedia, PFS, Metastasis, MD Anderson Cancer Center, ESR1, FDA, MBC, Neoplasm, Creatinine, Standard of care, Diarrhea, MD, Nausea, Cancer, Trial of the century, Death, Exemestane, Menarini, Anemia, SOC, TP53, Knowledge, Arthralgia, HIV disease progression rates, Triglyceride, Medical imaging, Pharmaceutical industry

This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.

Key Points: 
  • This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • ESR1 mutations are present in up to 40% of ER+, HER2- advanced or mBC.
  • “At Menarini Stemline our goal is to provide transformational treatments to help extend and improve the lives of people living with cancer.
  • See here for details of the Menarini Group/Stemline Therapeutics' full range of presentations at SABCS 2023.

Daiichi Sankyo Demonstrates Breadth and Depth of Oncology Portfolio Across Multiple Cancers with New Data at ESMO Asia, SABCS and ASH

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星期五, 十二月 1, 2023
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Lung, American Society of Hematology, Breast, Annual general meeting, Bone marrow, Fulvestrant, ASH, Acute myeloid leukemia, JST, ADC, Patient, Anastrozole, Lung cancer, TSE, Daiichi Sankyo, HER2, MD, R, AML, Cancer, Society, PTCL, NSCLC, Pharmaceutical industry

Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio in multiple types of solid and blood cancers at the 2023 ESMO Asia Congress (#ESMOAsia23), San Antonio Breast Cancer Symposium (#SABCS23) and American Society of Hematology (#ASH23) Annual Meeting prior to its annual R&D Day.

Key Points: 
  • Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio in multiple types of solid and blood cancers at the 2023 ESMO Asia Congress (#ESMOAsia23), San Antonio Breast Cancer Symposium (#SABCS23) and American Society of Hematology (#ASH23) Annual Meeting prior to its annual R&D Day.
  • “Our goal is to push the boundaries of science to change the way cancer is treated,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo.
  • Daiichi Sankyo will hold its annual R&D Day for investors, analysts and media on Monday, December 11 at 5:30 - 7:00 pm EST/Tuesday, December 12 at 7:30 - 9:00 am JST.
  • Company executives will provide highlights of Daiichi Sankyo’s research data presented at SABCS and ASH, as well as updates on the company’s R&D strategy.

Verastem Oncology Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

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星期三, 十一月 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Standard of care, NSCLC, Food, Pancreas, Anastrozole, Regulatory affairs, Ovarian cancer, GAAP, Pancreatic Cancer Action Network, Paclitaxel, Accelerated approval (FDA), ORR, European Network of Transmission System Operators for Electricity, Safety, Cancer, Therapy, Investment, Patient, General Administration of Sport of China, Verastem Oncology, Topotecan, Conference, Bank statement, Clinical trial, FRAME, Travel, Letrozole, RAMP, FDA, SOC, AACR, RAS, Research and development, The Annual Global Orgasm for Peace, GOG, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, KRAS, Senior, Pharmacokinetics, European Society of Gynaecological Oncology, Lung cancer, Table, Diagnosis, Pharmaceutical industry, Bank, Finance

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the third quarter ending September 30, 2023 and highlighted recent progress.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the third quarter ending September 30, 2023 and highlighted recent progress.
  • Verastem Oncology ended the third quarter of 2023 with cash, cash equivalents and investments of $165.7 million.
  • Research & development expenses for the 2023 Quarter were $13.9 million, compared to $11.3 million for the 2022 Quarter.
  • Selling, general & administrative expenses for the 2023 Quarter were $7.4 million, compared to $6.4 million for the 2022 Quarter.

Breast cancer prevention drug approved for post-menopausal women in the UK – here's how it works

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星期三, 十一月 8, 2023
Woman, Breast, Menopause, Testosterone, Obesity, Androstenedione, Anastrozole, Cell, Breast cancer, NHS, Disease, Risk, Cancer, Neoplasm, Hormone, Letrozole, Osteoporosis, Fracture, Patient, Bone density, Aromatase, Enzyme inhibitor, Birth control, Dietary supplement, Medical imaging

A drug that can halve the risk of developing breast cancer in post-menopausal women has been approved for use in the UK.

Key Points: 
  • A drug that can halve the risk of developing breast cancer in post-menopausal women has been approved for use in the UK.
  • This drug, called anastrozole, could benefit an estimated 289,000 women in the UK who are at increased risk of breast cancer.
  • Anastrozole was already approved for use in the UK as a breast cancer treatment.
  • The key to anaztrozole’s success both in treating and preventing breast cancer, is due to its effects on the body’s oestrogen levels.

Verastem Oncology Announces Efficacy and Safety Data of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Heavily Pretreated Patient Population

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星期一, 十一月 6, 2023
Research, General Health, Pharmaceutical, Oncology, Consumer, Clinical Trials, Science, Women, Biotechnology, FDA, Other Science, Health, Ovarian cancer, RAMP, Standard of care, SOC, Topotecan, Food, Lot, Soda Springs, The Annual Global Orgasm for Peace, Safety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, Paclitaxel, Disease, Memorial Sloan Kettering Cancer Center, FRAME, ORR, Letrozole, RECIST, Part, Cancer, Patient, Anastrozole, Verastem Oncology, Pharmaceutical industry

Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today results of the efficacy and safety of avutometinib and defactinib in recurrent low-grade serous ovarian cancer (LGSOC) following prior systemic therapy.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today results of the efficacy and safety of avutometinib and defactinib in recurrent low-grade serous ovarian cancer (LGSOC) following prior systemic therapy.
  • The analysis also evaluated efficacy in the context of best response to most recent prior treatment in the metastatic/recurrent setting.
  • The safety profiles of avutometinib and defactinib were similar in the less and more heavily pretreated subgroups and both analyses were consistent with previously reported safety data.
  • Dr. Grisham is a paid consultant for Verastem Oncology.

Quantum Leap Healthcare Collaborative Initiates Landmark Phase 2 RECAST DCIS Platform Trial to Evaluate Alternative DCIS Treatments with Atossa Therapeutics, Havah Therapeutics, and the Menarini Group

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星期一, 十月 30, 2023
DCIS, FDA, NCI, Atossa, Testosterone, Biomarker, SERM, MD, Breast disease, Growth, Ductal carcinoma, Disease, Risk, Tamoxifen, National Cancer Institute, Breast cancer, SAN, Woman, Safety, Anastrozole, Patient, Toxicity, Breast, Pharmaceutical industry, Birth control

SAN FRANCISCO, Oct. 30, 2023 /PRNewswire/ -- Quantum Leap Healthcare Collaborative (QLHC) announces the enrollment launch for the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. The study is evaluating three investigational endocrine therapy arms: (Z)-endoxifen, a selective estrogen receptor modulator (SERM) in development by Atossa Therapeutics (Nasdaq: ATOS); HAVAH T+Ai™, a proprietary combination of testosterone (T) and anastrozole (Ai) that targets the androgen and estrogen receptor pathways in development by Havah Therapeutics; and ORSERDU® (elacestrant), the only FDA approved oral selective estrogen receptor degrader (oSERD) in development by Stemline Therapeutics Inc. (Stemline), a wholly-owned subsidiary of the Menarini Group. 

Key Points: 
  • Surgery is the current standard treatment for DCIS even though many patients never progress to breast cancer, which means that patients are often over-treated with invasive procedures.
  • A key element in reducing overtreatment of DCIS is identifying biomarkers that reflect the risk of progression so that those with low-risk lesions are spared surgery.
  • RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting.
  • The three collaborators for this trial, Atossa Therapeutics, Havah Therapeutics, and Stemline, all aim to find alternative solutions for DCIS patients and are providing different agents for assessment.

Verastem Oncology Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

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星期二, 八月 8, 2023
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Topotecan, Pancreatic cancer, KRAS, Verastem Oncology, Avutometinib, Table, BIW, Pancreatic Cancer Action Network, Bank statement, General Administration of Press and Publication, Pancreas, Cancer, Paclitaxel, Anastrozole, GAAP, SOC, NSCLC, FRAME, Lung cancer, PFS, RAMP, Acquisition, HIV disease progression rates, RAS, Patient, Standard of care, Investment, European Society of Gynaecological Oncology, GOG, European Network of Transmission System Operators for Electricity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research and development, Society, Breakthrough, ORR, Letrozole, Food, Safety, Pharmaceutical industry, Transformer

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the second quarter ending June 30, 2023 and highlighted recent progress.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the second quarter ending June 30, 2023 and highlighted recent progress.
  • Verastem Oncology ended the second quarter of 2023 with cash, cash equivalents and investments of $183.1 million.
  • Research & development expenses for the 2023 Quarter were $12.9 million, compared to $14.9 million for the 2022 Quarter.
  • Selling, general & administrative expenses for the 2023 Quarter were $7.4 million, compared to $6.5 million for the 2022 Quarter.