AstraZeneca Pharmaceutical Co., Ltd.

Japan approved Merck and AstraZeneca’s Lynparza for use with abiraterone and prednisolone for BRCAm castration-resistant prostate cancer. Credit: Copyright © 2023 Merck & Co., Inc., Rahway, NJ USA, and its affiliates. Merck (MSD) and AstraZeneca have received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Lynparza to treat BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC) in adults. A poly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza is intended for use with abiraterone and prednisolone (abi/pred) for this indication. Recommended Reports Reports Japanese Encephalitis Drugs in Development by Stages, Target, MoA, RoA, Molecule Type and Key Pla... GlobalData Reports LOA and PTSR Model - Lipocurc in Gliosarcoma GlobalData View all Companies Intelligence AstraZeneca Plc Merck KGaA MSD KK NH&A LLC Ministry of Health View all The approval was based on an exploratory subgroup assessment of the double-blind, randomised Phase III PROpel clinical trial that analysed the safety, tolerability, and efficacy of Lynparza versus a placebo. According to the trial findings, treatment with Lynparza plus abi/pred showed improvements in radiographic progression-free survival and overall survival. The safety and tolerability of the Lynparza combination was found to be similar to that reported in previous trials and each medicine’s known profile. AstraZeneca oncology business unit executive vice-president Dave Fredrickson said: “This Lynparza combination has been shown to reduce the risk of disease progression or death compared to standard of care and underscores the critical importance of BRCA testing at metastatic diagnosis. “Today’s approval is a major step forward for patients in Japan with BRCAm mCRPC who urgently need new first-line treatment options.” The PARP inhibitor previously received approval in Japan for BRCAm mCRPC patients who have advanced after previous treatments comprising a new hormonal agent (NHA). Lynparza is also approved along with abi/pred for mCRPC in adults in various countries. In August 2022, Merck and AstraZeneca received European Commission (EC) approval for Lynparza as adjuvant treatment for high-risk, early-stage breast cancer.

Enhertu is indicated for use in adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Credit: Nephron / commons.wikimedia.org. The Chinese National Medical Products Administration has granted approval for AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) as a monotherapy to treat breast cancer. An antibody-drug conjugate (ADC) targeting the HER2 protein, Enhertu is indicated for use in adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Recommended Reports Reports LOA and PTSR Model - Paclitaxel Trevatide in Metastatic Breast Cancer GlobalData Reports LOA and PTSR Model - Dovitinib Lactate in Breast Cancer GlobalData View all Companies Intelligence AstraZeneca Plc Daiichi Sankyo Co Ltd View all These patients should have received a previous systemic treatment in the metastatic setting, or have experienced a recurrence of the condition during or within six months of receiving adjuvant chemotherapy. The latest approval is based on data from Phase III DESTINY-Breast04 clinical trial. Trial data showed that the therapy reduced disease progression or the risk of death by half, and boosted median overall survival by more than six months compared with physician’s choice of chemotherapy. In February 2023, the ADC was approved for treating priorly treated unresectable or metastatic HER2-positive breast cancer . AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “The results from the DESTINY-Breast04 trial show Enhertu provides a significant improvement in outcomes compared to chemotherapy for patients whose tumours are determined to be HER2-low via routine testing. “This approval is an important advance in the way breast cancer is classified and treated in China and supports our vision to bring Enhertu to more patients worldwide.”

阿斯利康（AstraZeneca）今日宣布其药品capivasertib与Faslodex（fulvestrant）联用的新药申请（NDA）已获美国FDA接受并被授予优先审评资格，用于治疗荷尔蒙受体（HR）阳性，人表皮生长因子受体2（HER2）阴性局部晚期或转移性乳腺癌的成年患者，这些患者在接受内分泌疗法后产生复发或疾病进展。FDA预计在2023年的第四季度完成审评。根据新闻稿，capivasertib是在FDA的Orbis项目下审查的潜在“first-in-class”AKT抑制剂。 HR阳性/HER2阴性乳腺癌是最常见的乳腺癌类型，约占所有新发病例的70%。在HR阳性/HER2阴性转移性疾病患者中，五年生存率为30%。随着这些患者对基于内分泌的治疗产生耐药性，其主要治疗选择仅限于单药化疗，预后仍然较差。 Capivasertib为一具选择性、靶向3种AKT激酶异形体（AKT1/2/3）的腺苷三磷酸（ATP）竞争性抑制剂。此口服在研药品在许多临床项目中，获检视作为潜力疗法治疗带有PI3K/AKT/PTEN信息通路变异的肿瘤。此药品在2023年1月获FDA授予快速通道资格。 此NDA的递交是基于在2022年的圣安东尼奥乳腺癌研讨会上展示，并最近在《新英格兰医学杂志》在线发表的CAPItello-291临床3期试验数据。 在试验中，capivasertib与Faslodex联用相比安慰剂加Faslodex在整体试验人群中降低了疾病进展或死亡风险达40%（HR=0.60，95% CI：0.51-0.71；p=<0.001；中位无进展生存期[PFS] 7.2月vs 3.6月）。尽管在分析时总生存期（OS）数据尚未成熟，但早期数据令人鼓舞。该试验将继续评估关键次要终点OS。 安全性方面，capivasertib与Faslodex联用的安全性特征与先前试验中所观察到的结果类似。 参考资料：[1] Capivasertib in combination with Faslodex granted Priority Review in the US for patients with advanced HR-positive breast cancer. Retrieved June 12, 2023 from https://www.astrazeneca.com/media-centre/press-releases/2023/capivasertib-in-combination-with-faslodex-granted-priority-review-in-the-us.html 内容来源于网络，如有侵权，请联系删除。