Neratinib

Transcenta Announces the Appointment of Dr. Caroline Germa as Executive Vice President, Global Medicine Development and Chief Medical Officer

Retrieved on: 
Monday, August 8, 2022
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Prior to joining Transcenta, Dr. Germa served as the Vice President and Head of the Early Development Clinical Group for AstraZeneca oncology department.

Key Points: 
  • Prior to joining Transcenta, Dr. Germa served as the Vice President and Head of the Early Development Clinical Group for AstraZeneca oncology department.
  • During her time at AstraZeneca, Dr. Germa built an Early Development Clinical Group with over 180 staff and guided the clinical development of the early oncology portfolio.
  • "I would like to express my warmest welcome to Dr. Germa on her appointment," said Dr. Xueming Qian, CEO of Transcenta.
  • I am thrilled to join Transcenta at this important juncture," said Dr. Caroline Germa, Executive Vice President, Global Medicine Development and Chief Medical Officer of Transcenta.

HER2+ Breast Cancer Disease Market Analysis Research Report 2021 - Pipeline Drugs will Face Strong Competition in a Saturated Market - ResearchAndMarkets.com

Retrieved on: 
Friday, January 28, 2022
Pharmaceutical, Health, Oncology, Breast cancer, Brain, Puma Biotechnology, Patient, Roche, Probability, Lapatinib, Population, Neratinib, Diarrhea, AstraZeneca, Phase, Trastuzumab, Survival, Daiichi Sankyo, Dietary supplement, Pharmaceutical industry, Trastuzumab emtansine, Pertuzumab/trastuzumab/hyaluronidase, Margetuximab

The publisher estimates that in 2018, there were 2.1 million incident cases and 8.6 million five-year prevalent cases of breast cancer worldwide.

Key Points: 
  • The publisher estimates that in 2018, there were 2.1 million incident cases and 8.6 million five-year prevalent cases of breast cancer worldwide.
  • By 2027, incident and five-year prevalent cases of breast cancer are expected to increase to 2.3 million and 9.3 million cases, respectively.
  • Furthermore, the market for HER2+ breast cancer is also becoming increasingly crowded, creating fierce competition among approved and pipeline therapies.
  • Breast cancer drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.

NCCN Announces Selected Projects to Study Neratinib in Collaboration with Puma Biotechnology, Inc.

Retrieved on: 
Thursday, July 15, 2021
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Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert medical oncologists from NCCN Member Institutions.

Key Points: 
  • Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert medical oncologists from NCCN Member Institutions.
  • Puma is providing $1.4 million in funding and will also supply the neratinib tablets for use in the studies.
  • In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database .
  • Visit NCCN.org for more information and follow NCCN on Facebook @NCCNorg , Instagram @NCCNorg , and Twitter @NCCN .

FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer

Retrieved on: 
Thursday, July 1, 2021
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HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.

Key Points: 
  • HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.
  • Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.
  • INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:
    As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
  • Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

Puma Biotechnology Presents Data Comparing Findings from the Phase II CONTROL Trial with the Neratinib Arm of the Phase III ExteNET Trial at the ASCO 2021 Annual Meeting

Retrieved on: 
Friday, June 4, 2021
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In the analysis presented at ASCO 2021, five CONTROL cohorts that had completed follow up were evaluated for 13 endpoints related to tolerability.

Key Points: 
  • In the analysis presented at ASCO 2021, five CONTROL cohorts that had completed follow up were evaluated for 13 endpoints related to tolerability.
  • Comparison of the CONTROL DE cohort with the ExteNET neratinib arm demonstrated that grade 3 diarrhea was substantially lower in CONTROL DE compared to ExteNET (13.3% vs. 39.9%).
  • Neratinib DE also resulted in fewer total days of grade 3 diarrhea compared to ExteNET (2.5 days vs 5 days).
  • Additionally, the average duration of treatment with neratinib was much longer in the DE cohort versus ExteNET.

Puma Biotechnology Presents Data from the EGFR Exon 18-mutant NSCLC Cohort of the Phase II SUMMIT Trial at the 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Organic compounds, Chemical compounds, Aromatic compounds, Lung cancer, Chloroarenes, Quinazolines, Aromatic amines, Tyrosine kinase receptors, Neratinib, Tyrosine kinase inhibitor, Epidermal growth factor receptor, Non-small-cell lung carcinoma

The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that includes a cohort evaluating the safety and efficacy of neratinib administered daily to patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC).

Key Points: 
  • The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that includes a cohort evaluating the safety and efficacy of neratinib administered daily to patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC).
  • A cohort of 11 patients with EGFR exon 18-mutant NSCLC from the Phase II SUMMIT basket trial, including patients with central nervous system involvement, were evaluated for safety and efficacy.
  • Prior lines of therapies included EGFR tyrosine kinase inhibitors (TKIs) (91%), chemotherapy (55%) and checkpoint inhibitors (IOs) (27%).
  • These results suggest that neratinib can be a potential treatment option for patients with NSCLC and hard-to-treat CNS metastases.

Puma Biotechnology Presents Data from the Phase III ExteNET Trial in Early Stage HER2-Positive Breast Cancer Patients at the Virtual 2021 ASCO Annual Meeting

Retrieved on: 
Friday, June 4, 2021
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Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented results from the Phase III ExteNET trial assessing the impact of neratinib treatment duration on overall survival (OS) in patients with early stage HER2-positive breast cancer at the virtual 2021 ASCO Annual Meeting.

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented results from the Phase III ExteNET trial assessing the impact of neratinib treatment duration on overall survival (OS) in patients with early stage HER2-positive breast cancer at the virtual 2021 ASCO Annual Meeting.
  • ExteNET was a multicenter, randomized, double-blind, Phase III trial of 2,840 HER2-positive early stage breast cancer patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab-based treatment.
  • These descriptive findings suggest that overall survival in patients with early stage HER2-positive breast cancer patients is improved upon completion of neratinib extended adjuvant therapy.
  • HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.

Puma Biotechnology Announces Publication of Abstracts on Neratinib for the 2021 ASCO Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Organic compounds, Chemical compounds, Puma Biotechnology, Aromatic compounds, Quinolines, Asco, Neratinib, Puma, American Society of Clinical Oncology

b'Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced publication of three abstracts on neratinib for the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021.

Key Points: 
  • b'Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced publication of three abstracts on neratinib for the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021.
  • Puma will present three posters with audio recordings, the corresponding abstracts of which are now live on the 2021 ASCO Annual Meeting website.
  • Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.
  • NERLYNX is a registered trademark of Puma Biotechnology, Inc.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210519005103/en/\n'

Puma Biotechnology to Host Conference Call to Discuss First Quarter Financial Results

Retrieved on: 
Thursday, April 22, 2021
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b'Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 6, 2021, following the release of its first quarter 2021 financial results.\nThe call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international).

Key Points: 
  • b'Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 6, 2021, following the release of its first quarter 2021 financial results.\nThe call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international).
  • Please dial in at least 10 minutes in advance and inform the operator that you would like to join the \xe2\x80\x9cPuma Biotechnology Conference Call.\xe2\x80\x9d A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at http://www.pumabiotechnology.com .
  • Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.
  • NERLYNX is a registered trademark of Puma Biotechnology, Inc.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210422005925/en/\n'

Puma Biotechnology to Present at the Barclays Global Healthcare Conference

Retrieved on: 
Thursday, March 4, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Organic compounds, Chemical compounds, Puma Biotechnology, Aromatic compounds, Societates Europaeae, Puma, Neratinib

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at the Barclays Global Healthcare Conference, which will be held virtually from March 9-11, 2021.

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at the Barclays Global Healthcare Conference, which will be held virtually from March 9-11, 2021.
  • Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.
  • Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.
  • NERLYNX is a registered trademark of Puma Biotechnology, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210304005082/en/