Weekly Top News – Breast Cancer – July 22, 2019

July 22, 2019

Halaven (eribulin mesylate) / Eisai
Anticancer agent Halaven approved for treatment of locally advanced or metastatic breast cancer in China (Eisai Press Release) – Jul 17, 2019 – “Eisai Co., Ltd….announced today that Eisai received New Drug Approval for Eisai’s in-house developed anticancer agent Halaven® (eribulin mesylate) for use in the treatment of patients with locally advanced or metastatic breast cancer, previously treated with at least two prior chemotherapy regimens, including an anthracycline and a taxane, from the China National Medical Products Administration (NMPA). This approval is based on the results of Study 304…Halaven demonstrated a statistically significant extension in the study’s primary endpoint of progression-free survival (PFS) over the comparator treatment vinorelbine according to independent imaging review (Hazard Ratio: 0.80; 95% Confidence Interval: 0.65-0.98; p = 0.036).”


Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Primary completion of P3 KEYNOTE-522 trial (NCT03036488) for TNBC in September 2025 and interim data from the trial in Q4 2019 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 437; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019


Piqray (alpelisib) / Novartis
Piqray: Regulatory submissions in US for HER2+ breast cancer, TNBC, 2L/3L HNSCC and ovarian cancer in 2023 or later (Novartis) – Jul 18, 2019 – Q2 2019 Results: CHMP opinion in EU for breast cancer in H2 2019   


Verzenio (abemaciclib) / Eli Lilly
Verzenio clinical trial estimate: Data from P3 monarchE trial (NCT03155997) in HR+/HER2- breast cancer in 2021 (Cowen & Co) – Jul 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67616307; Page no: 333; REPORT TITLE: “Pharmaceutical industry pulse”; AUTHOR: Scala, Stephen, et al; DATE: 07/11/2019


Kisqali (ribociclib) / Novartis
NICE U-turn for Kisqali in breast cancer (PharmaTimes) – Jul 17, 2019 – “The National Institute of Health and Care Excellence (NICE) has recommended Novartis’ Kisqali (ribociclib) for use on the NHS in combination with fulvestrant, where exemestane plus everolimus is the most appropriate alternative…The recommendation is based on the second line subpopulation of the MONALEESA-3 trial…There will be immediate access to the combination treatment in England through the Cancer Drugs Fund (CDF) and in Wales through the Welsh New Treatment Fund, whilst Novartis await the NICE Technology Appraisal.”


Nerlynx (neratinib) / Puma
Puma Biotechnology’s licensing partner Knight Therapeutics receives regulatory approval from Health Canada to commercialize Nerlynx (neratinib) for extended adjuvant treatment of hormone receptor positive, HER2-positive early stage breast cancer (Businesswire) – Jul 16, 2019 – “Puma Biotechnology…announced that its licensing partner Knight Therapeutics Inc. (Knight) has received marketing authorization from Health Canada to commercialize NERLYNX® (neratinib) in Canada for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy…Health Canada approval was based on the Phase III ExteNET trial…Treatment with neratinib in the approved Health Canada indication resulted in a 51% reduction in the risk of invasive disease recurrence or death at 2 years versus placebo after patients completed one year of therapy following a trastuzumab-based regimen.”


Mvasi (bevacizumab biosimilar) / Daiichi Sankyo, Amgen, Allergan; Kanjinti (trastuzumab biosimilar) / Amgen, Daiichi Sankyo, Allergan
Amgen and Allergan’s Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) now available in the United States (Amgen Press Release) – Jul 18, 2019 – “Amgen…announced that MVASI (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTI (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), are now available in the United States (U.S.). MVASI…is approved for the treatment of five types of cancer: mCRC, NSCLC, recurrent glioblastoma, metastatic renal cell carcinoma and metastatic cervical cancer. KANJINTI is FDA approved for all approved indications of Herceptin: for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.”


Piqray (alpelisib) / Novartis
Novartis delivers strong sales, double digit core operating income growth and launches Zolgensma and Piqray in second quarter; sales and profit guidance increased (Novartis Press Release) – Jul 18, 2019 – “Piqray (alpelisib, formerly BYL719) was approved and launched in the US as the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer.”

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