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Otsuka Pharmaceutical Co Ltd's (Otsuka) wholly owned subsidiary Astex Pharmaceuticals in Cambridge, UK, (Astex), announced that it will receive a milestone payment from AstraZeneca PLC (AstaZeneca) on first commercial sale of the drug Truqap and receive royalties from AstraZeneca on future sales following US FDA approval of Truqap plus Faslodex as a treatment for adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. Original source: Otsuka Holdings Co Ltd, website: http://www.otsuka.com/en/, Copyright Otsuka Holdings Co Ltd 2023., joint venture; anticancer drugs; fulvestrant; Truqap; Astex Pharmaceuticals; AstraZeneca; Otsuka [...]

Otsuka Pharmaceutical Co Ltd's (Otsuka) wholly owned subsidiary Astex Pharmaceuticals in Cambridge, UK, (Astex), announced that it will receive a milestone payment from AstraZeneca PLC (AstaZeneca) on first commercial sale of the drug Truqap and receive royalties from AstraZeneca on future sales following US FDA approval of Truqap plus Faslodex as a treatment for adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. Truqap is a first-in-class oral targeted inhibitor of the cancer-driving protein AKT, also known as PKB. Truqap was discovered by AstraZeneca following an earlier drug discovery research collaboration between Astex, The Institute of Cancer Research, London, and Cancer Research Technology (now Cancer Research Horizons) that was signed in 2003. As part of that earlier foundational research, Astex and The Institute of Cancer Research used the 3D X-ray crystal structure of the AKT protein target to identify small molecule modulators of AKT activity using an approach known as fragment-based drug discovery. Original source: Otsuka Pharmaceutical Co Ltd, website: http://www.otsuka.co.jp/en/, Copyright Otsuka Pharmaceutical Co Ltd 2023., joint venture; regulations and rulings; research and development; anticancer drugs; enzyme inhibitors; fulvestrant; Truqap; Astex Pharmaceuticals; AstraZeneca; Otsuka [...]

AstraZeneca's New Drug Application (NDA) for capivasertib in combination with Faslodex (fulvestrant) has been accepted and granted Priority Review in the US for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during 4Q 2023. The NDA is also being reviewed under Project Orbis, an initiative of the FDA which provides a framework for concurrent submission and review of oncology medicines among participating international partners to expedite approval for patients around the world. The NDA is based on data from the CAPItello-291 Phase III trial presented at the 2022 San Antonio Breast Cancer Symposium and recently published online in The New England Journal of Medicine. In the trial, capivasertib in combination with Faslodex demonstrated a 40% reduction in the risk of disease progression or death versus placebo plus Faslodex in the overall trial population. Although the overall survival (OS) data were immature at the time of the analysis, early data are encouraging. The trial continues to assess OS as a key secondary endpoint. The safety profile of capivasertib plus Faslodex was similar to that observed in previous trials evaluating this combination. Original source: AstraZeneca, website: http://www.astrazeneca.com, Copyright AstraZeneca 2023., regulations and rulings; research and development; anticancer drugs; capivasertib; fulvestrant; fulvestrant; [...]

AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-low breast cancer who have received a prior therapy in the metastatic setting. The application has been granted Priority Review. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during 4Q 2022. The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two initiatives of the FDA which are designed to bring safe and effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners. The sBLA is based on data from the DESTINY-Breast04 Phase III trial that were presented at the presidential plenary session of the 2022 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. In the trial, Enhertu demonstrated superior and clinically meaningful efficacy in progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2-low metastatic breast cancer with hormone receptor (HR)-positive or HR-negative disease versus standard of care physician's choice of chemotherapy. The safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified. Interstitial lung disease or pneumonitis rates were consistent with that observed in late-line HER2-positive breast cancer trials of Enhertu, as determined by an independent adjudication committee. The majority (10%) were primarily low Grade (Grade 1 or 2) with five Grade 3 (1.3%), no Grade 4 and three Grade 5 (0.8%) events reported. This Priority Review follows receipt of Breakthrough Therapy Designation (BTD) in the US in Apr 2022 in metastatic HER2-low breast cancer, the fifth BTD in the US for Enhertu. Regulatory reviews for Enhertu in the HER2-low patient population are also underway in the European Union (EU) and Japan, and Enhertu is already approved in the US, the EU and many other countries across the globe for patients with previously treated HER2-positive (IHC 3+ or IHC 2+/ISH-positive) metastatic breast cancer. Original source: AstraZeneca, website: http://www.astrazeneca.com, Copyright AstraZeneca 2022., joint venture; regulations and rulings; research and development; anticancer drugs; Enhertu; monoclonal antibodies; therapeutic antibodies; trastuzumab deruxtecan; AstraZeneca; Daiichi [...]

Daiichi Sankyo announced on 27 Jun 2022 that it has submitted a supplemental New Drug Application (sNDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for trastuzumab deruxtecan for the treatment of adult patients in Japan with HER2 low unresectable or recurrent breast cancer after prior chemotherapy. The sNDA is based on data from the DESTINY-Breast04 phase 3 trial recently presented at the plenary session of the American Society of Clinical Oncology (ASCO22) annual meeting and simultaneously published in The New England Journal of Medicine. In DESTINY-Breast04, trastuzumab deruxtecan demonstrated superior and clinically meaningful efficacy in progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2 low unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR negative disease versus standard of care physician's choice of chemotherapy. The safety profile of trastuzumab deruxtecan was consistent with previous clinical trials with no new safety concerns identified. Interstitial lung disease (ILD) or pneumonitis rates were consistent with that observed in late-line HER2 positive breast cancer trials of trastuzumab deruxtecan with a lower rate of grade 5 ILD observed, as determined by an independent adjudication committee. Original source: Daiichi Sankyo Co Ltd, website: http://www.daiichisankyo.com/, Copyright Daiichi Sankyo Company Limited 2022., regulations and rulings; research and development; anticancer drugs; monoclonal antibodies; therapeutic antibodies; trastuzumab deruxtecan; Daiichi [...]

AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen. The application has also been granted priority review. Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. The Food and Drug Administration (FDA) grants priority review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during 2Q 2022. The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two initiatives of the FDA which are designed to bring effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners. Despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression. More treatment options are needed to further delay progression and extend survival. The sBLA is based on data from the DESTINY-Breast03 trial presented during the European Society for Medical Oncology (ESMO) Congress 2021. In the trial, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. DESTINY-Breast03 also recorded that nearly all patients treated with Enhertu during the trial were alive at one year (94.1%) compared to 85.9% of patients treated with T-DM1. Confirmed objective response rate (ORR) more than doubled in the Enhertu arm versus the T-DM1 arm (79.7% vs 34.2%). The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events. In Sep 2021, Enhertu received its fourth Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. Enhertu is approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in more than 30 countries based on the results from the DESTINY-Breast01 trial. Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Original source: AstraZeneca, website: http://www.astrazeneca.com, Copyright AstraZeneca 2022., joint venture; regulations and rulings; research and development; anticancer drugs; Enhertu; monoclonal antibodies; taxanes; therapeutic antibodies; trastuzumab; trastuzumab deruxtecan; AstraZeneca; Daiichi [...]

Daiichi Sankyo Company Limited and AstraZeneca have received notification of acceptance by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) of ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients in the US with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen. The application has also been granted Priority Review. ENHERTU is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date (PDUFA), the FDA action date for their regulatory decision, is during the 2Q 2022. The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) programme and Project Orbis, two initiatives of the FDA which are designed to bring effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners. The sBLA is based on data from the pivotal DESTINY-Breast03 phase 3 trial that were presented at the 2021 European Society for Medical Oncology (ESMO) Congress. In the trial, ENHERTU demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 [hazard ratio (HR) = 0.28; 95% confidence interval (CI): 0.22-0.37; p=7.8x0.000000000000000000001] in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The median progression-free survival (PFS) for patients treated with ENHERTU was not reached (95% CI: 18.5-NE) compared to 6.8 months for T-DM1 (95% CI: 5.6-8.2) as assessed by blinded independent central review (BICR). In the secondary endpoint analysis of PFS assessed by investigators, patients treated with ENHERTU experienced an improvement in PFS of 25.1 months (95% CI: 22.1-NE) compared to 7.2 months (95% CI: 6.8-8.3) for T-DM1 (HR=0.26; 95% CI: 0.20-0.35). There was a strong trend towards improved overall survival (OS) with ENHERTU (HR=0.56; 95% CI: 0.36-0.86; p=0.007172), however, this analysis is not yet mature and is not statistically significant. Nearly all patients treated with ENHERTU during the trial were alive at one year (94.1%; 95% CI: 90.3-96.4) compared to 85.9% of patients treated with T-DM1 (95% CI: 80.9-89.7). Confirmed objective response rate (ORR) was more than doubled in the ENHERTU arm versus the T-DM1 arm (79.7%; n=208; 95% CI: 74.3-84.4) versus 34.2% (n=90; 95% CI: 28.5-40.3; p less than 0.0001). The safety profile of the most common adverse events with ENHERTU in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns identified. Original source: Daiichi Sankyo Co Ltd, website: http://www.daiichisankyo.com/, Copyright Daiichi Sankyo Company Limited 2022., joint venture; regulations and rulings; research and development; anticancer drugs; ENHERTU; fam-trastuzumab deruxtecan-nxki; monoclonal antibodies; therapeutic antibodies; AstraZeneca; Daiichi [...]

Medifocus Inc announced that VM Medical Center in Montreal, its principal investigational site in Canada for its APA-1000 Focused Microwave Breast Thermotherapy System Pivotal Phase III clinical study, has successfully [...]

On 5 Dec 2013, biopharmaceutical company Puma Biotechnology Inc (PBYI) announced the top line results from the phase II clinical trial of Puma's investigational drug PB272 (neratinib) for the neoadjuvant [...]

An approval from the Drugs Controller General of India was received by biotechnology firm Biocon Ltd to market its biosimilar trastuzumab, a breast cancer medicine. Biosimilar trastuzumab is the first [...]

On 26 Nov 2013, biotechnology company Biocon announced that it was authorized by the Drug Controller General of India (DCGI) to sell its biosimilar trastuzumab product for use as treatment [...]

Eisai announces that Halaven (eribulin) will be marketed in selected countries within the Middle East region through a new partnership between Eisai EMEA (Europe, the Middle East, Africa, Russia and [...]

IceCure Medical Ltd announced that the John Wayne Cancer Institute (JWCI) at Saint John's Health Center in Santa Monica, CA, treated its first breast cancer patient using the IceSense3 Cryoablation [...]

Nanoparticles filled with chemotherapeutic drugs can kill drug-resistant breast cancer cells, according to a study published in the scientific journal Biomaterials. In the present study, researchers from Karolinska Institutet have [...]

Halaven (eribulin) has received reimbursement approval in Belgium as a novel treatment for patients with metastatic breast cancer. Eribulin is the first, single-agent chemotherapy to demonstrate a prolonged overall survival [...]

Genentech, a member of the Roche Group, announced that the US Food and Drug Administration (FDA) granted accelerated approval of a Perjeta (pertuzumab) regimen for neoadjuvant treatment (use before surgery) [...]

Genentech, a member of the Roche Group, announced that the US Food and Drug Administration (FDA) granted accelerated approval of a Perjeta (pertuzumab) regimen for neoadjuvant treatment (use before surgery) [...]

On 30 Sep 2013, the US Food and Drug Administration granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer [...]

Eisai EMEA (Europe, Middle East, Africa, Russia and Oceania), a division of one of the world's leading research and development (R&D) based pharmaceutical companies, has opened a new business operation [...]

On 16 Sep 2013, the US Food and Drug Administration approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or [...]

Syndax Pharmaceuticals Inc announced that the US Food and Drug Administration (FDA) has designated entinostat as a Breakthrough Therapy for the treatment of locally recurrent or metastatic oestrogen receptor-positive (ER+) [...]

Reimbursement granted for Halaven (eribulin) for patients with locally advanced or metastatic breast cancer Halaven(eribulin), has received reimbursement approval from The Spanish Directorate General of Pharmacy and Health Products, belonging [...]

Bio-Matrix Scientific Group Inc (Bio-Matrix) provided an update on the cancer immunotherapy programme currently under development by Regen BioPharma Inc, a wholly owned subsidiary of Bio-Matrix. On 6 May 2013, [...]

In a new paper in Cancer Cell, a team led by Judy Lieberman, PhD, of Boston Children's Hospital's Programme in Cellular and Molecular Medicine reports triple-negative breast cancers may be [...]

Medifocus Inc is pleased to announce that it has initiated its Principal Investigational Site in Canada for its APA-1000 Focused Microwave Breast Thermotherapy System Pivotal Phase III clinical study. Dr [...]

Medifocus Inc is pleased to announce that it has initiated its Principal Investigational Site in Canada for its APA-1000 Focused Microwave Breast Thermotherapy System Pivotal Phase III clinical study. Dr [...]

Pfizer Inc must pay about $1.8 M in punitive damages to a Connecticut woman who developed breast cancer after taking the company's Prempro menopause drug, a judge concluded. US District [...]

Sorrento Therapeutics, Inc and IGDRASOL announced that IGDRASOL has received official meeting minutes from an End-of-Phase II meeting for Cynviloq (or IG-001) with the US Food and Drug Administration (FDA). [...]

Pfizer developed the cancer drug palbociclib, an inhibitor of cyclin-dependent kinases 4 and 6 for metastasising breast cancer. Researchers at Pfizer showed an impressive proof for the effectiveness of Palbociclib [...]

Synta Pharmaceuticals Corp announced that preliminary results from the ENCHANT-1 clinical trial, which evaluates ganetespib monotherapy in patients with newly diagnosed locally advanced or metastatic HER2 positive or triple-negative breast [...]

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Zhejiang Medicine Co will collaborate with Ambrx of San Diego to develop an Ambrx molecule that targets Her2-positive breast cancer; Suzhou Ribo Life Sciences acquired China Rights to Life Technologies' [...]

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Sunshine Biopharma Inc has completed a new IND-Enabling study in which Adva-27a, the company's flagship oncology drug candidate for breast cancer was found to be effective at killing Pancreatic Cancer [...]

TESARO Inc, an oncology-focused biopharmaceutical company, Breast International Group, a non-profit organization for academic breast cancer research groups from around the world, and the European Organization for Research and Treatment [...]

A study involving 7000 women led by the University of Birmingham in the UK revealed that patients who underwent tamoxifen treatment for 10 years had 23% fewer recurrences of breast [...]

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Sunshine Biopharma Inc reported that following negotiations with several Contract Manufacturing Organizations (CMOs) for the GMP (Good Manufacturing Practice) manufacturing of 1 kg of Adva-27a breast cancer drug candidate, the [...]

Sunshine Biopharma Inc is pleased to report that following negotiations with several Contract Manufacturing Organizations (CMOs) for the GMP (Good Manufacturing Practice) manufacturing of one kilogram of Adva-27a breast cancer [...]

The EU approved a new treatment for breast cancer, Perjeta concentrate to obtain an infusion solution with the recombinant humanised monoclonal IgG1-antibody pertuzumab, which binds to the epidermal growth factor [...]

Galapagos NV announced that it developed GLPG1790, a novel candidate drug to treat breast cancer. GLPG1790 has shown high activity against breast tumours that are triple- negative, for which the [...]

Eddingpharm (Cayman) Inc, a Shanghai company, signed a collaboration agreement with GlaxoSmithKline China that gives Eddingpharm exclusive rights to market and distribute Tykerb in China. Tykerb was recently approved by [...]

NewLink Genetics Corp, a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, announced the initiation of a double-blind, randomized, placebo-controlled Phase II clinical study of its first IDO [...]

Sunshine Biopharma Inc reported that it has commenced negotiations with several Contract Manufacturing Organizations (CMO's) for the GMP (Good Manufacturing Practice) manufacturing of 1 kg of Adva-27a, the company's flagship [...]

Dako, an Agilent Technologies company and worldwide provider of cancer diagnostics, has received approval from the US Food and Drug Administration (FDA) for the addition of Kadcyla in the labelling [...]

Bioengineering researchers at University of California, Santa Barbara have found that changing the shape of chemotherapy drug nanoparticles from spherical to rod-shaped made them up to 10,000 times more effective [...]

Sunshine Biopharma Inc provided an update on the progress of the IND-Enabling studies of Adva-27a, the company's flagship oncology drug candidate. As of 26 Feb 2013, the company has completed [...]

Sunshine Biopharma Inc is pleased to provide an update on the progress of the IND-Enabling studies of Adva-27a, the company's flagship oncology drug candidate. To date, the company has completed [...]

On 22 Feb 2013 Roche announced that the US Food and Drug Administration had approved Kadcyla (trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer [...]

Genentech announced that the US Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have [...]