Letrozole

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

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Wednesday, March 20, 2024
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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.

Onconova Therapeutics’ Narazaciclib ASH Poster Highlights Activity in Treatment Resistant Mantle Cell Lymphoma

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Tuesday, December 12, 2023
Diarrhea, Breast, Ibrutinib, Cell Cycle, Result, Neutropenia, Letrozole, DNA, Metabolism, G1, Society, Therapy, Cancer, ASH, DNA repair, Vivo, Ovary, Poster, Patient, Safety, MCL, Pharmaceutical industry

NEWTOWN, Pa., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova” or “the Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced preclinical data, highlighting narazaciclib’s preclinical activity in Bruton’s kinase inhibitor (BTKi)-resistant mantle cell lymphoma (MCL), in a poster presented on December 11, 2023 at the 65th Annual Meeting of the American Society for Hematology (ASH 2023) in San Diego.

Key Points: 
  • “We are pleased to have shared data at ASH 2023 from preclinical studies with narazaciclib in MCL models.
  • The data presented at SABCS highlight narazaciclib’s multi-kinase activity, its ability to target resistance pathways missed by other CDK4/6 inhibitors, and its differentiated anti-tumor and immunomodulatory activity.
  • Cell Cycle Blockade: The combination of narazaciclib plus ibrutinib induces a superior G1 cell cycle blockade in both ibrutinib-sensitive and ibrutinib-resistant MCL cells.
  • A copy of the poster is available on the “ Scientific Presentations ” section of the Onconova website.

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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Wednesday, December 13, 2023
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“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

Retrieved on: 
Monday, December 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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Friday, December 8, 2023
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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.

SABCS23: Reveal Genomics® Unleashes Groundbreaking DNADX® Liquid Biopsy Data for Metastatic Breast Cancer

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Monday, December 4, 2023
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REVEAL GENOMICS, S.L., a pioneering biotechnology start-up headquartered in Barcelona committed to advancing cancer care through innovative diagnostic solutions, emphasized the excellent results of DNADX® in data presented at the San Antonio Breast Cancer Symposium 2023 (SABCS23).

Key Points: 
  • REVEAL GENOMICS, S.L., a pioneering biotechnology start-up headquartered in Barcelona committed to advancing cancer care through innovative diagnostic solutions, emphasized the excellent results of DNADX® in data presented at the San Antonio Breast Cancer Symposium 2023 (SABCS23).
  • View the full release here: https://www.businesswire.com/news/home/20231204265236/en/
    The RELIEVE study, conducted by the Dana-Farber Cancer Institute (DFCI), analyzed plasma samples from patients with HER2+ and HER2- metastatic breast cancer receiving T-DXd monotherapy.
  • DNADX® subtypes, evaluated across 80 pre-treatment plasma samples, exhibited significant associations with time-to-next-treatment (TTNT) and overall survival (OS).
  • This endorsement not only signifies the recognition of DNADX® as an innovative tool, but also underscores its clinical utility.”

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

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Wednesday, November 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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Wednesday, November 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

Retrieved on: 
Monday, November 6, 2023
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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.

Oncolytics Biotech® Reports Third Quarter 2023 Financial Results and Operational Highlights

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Friday, November 3, 2023
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SAN DIEGO and CALGARY, AB, Nov. 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the third quarter ended September 30, 2023. All dollar amounts are expressed in Canadian currency unless otherwise noted.

Key Points: 
  • ET
    SAN DIEGO and CALGARY, AB, Nov. 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced recent operational highlights and financial results for the third quarter ended September 30, 2023.
  • General and administrative expenses for the third quarter of 2023 were $5.2 million, compared to $2.4 million for the third quarter of 2022.
  • Research and development expenses for the third quarter of 2023 were $5.8 million, compared to $3.7 million for the third quarter of 2022.
  • The net loss for the third quarter of 2023 was $9.9 million, compared to a net loss of $4.4 million for the third quarter of 2022.