With Enhertu at the heart of AstraZeneca and Daiichi Sankyo’s respective goals for oncology growth, the partners have significantly expanded the antibody-drug conjugate’s (ADC's) reach in the U.S.Late last week, the FDA granted an accelerated approval for Enhertu to treat adults with unresectable or metastatic HER2-positive solid tumors.

由于Enhertu是阿斯利康（AstraZeneca）和第一三共（Daiichi Sankyo）各自的肿瘤学发展目标的核心，合作伙伴已经显着扩大了抗体-药物偶联物（ADC）在美国的覆盖范围。上周晚些时候，FDA批准Enhertu加速治疗无法切除或转移性HER2阳性实体瘤的成年人。

The approval makes Enhertu the first FDA approved tumor-agnostic HER2-directed ADC and clears the drug for use in patients who’ve already received primary systemic treatment and have no other satisfactory alternatives, AZ said in a Friday release.Because AZ and Daiichi’s latest Enhertu approval utilized the FDA’s accelerated pathway, the partners will likely have to run a confirmatory trial to verify the drug’s benefit and keep hold of their new green light.

AZ在周五的一份新闻稿中表示，该批准使Enhertu成为FDA批准的首个不依赖肿瘤的HER2定向ADC，并清除了该药物用于已经接受初步全身治疗且没有其他令人满意替代品的患者。由于AZ和Daiichi的最新Enhertu批准使用了FDA的加速途径，因此合作伙伴可能必须进行验证性试验，以验证该药物的益处并保持他们的新绿灯。

The accelerated nod is based on objective response rate (ORR) and duration of response (DoR) findings from a midstage study.The latest nod marks Enhertu’s fifth approved indication in the U.S. The ADC, which won its original nod in 2019, is also cleared to treat HER2-positive and HER2-low breast cancer, plus gastric cancer and non-small cell lung cancer (NSCLC).The FDA based Enhertu’s tumor-agnostic approval on results from the phase 2 trial DESTINY-PanTumor02, which looked at patients with HER2-positive tumors including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors.

加速nod基于中期研究的客观缓解率（ORR）和缓解持续时间（DoR）结果。最新的nod标志着Enhertu在美国第五次获得批准。ADC于2019年获得了最初的nod，也被批准用于治疗HER2阳性和HER2低乳腺癌，以及胃癌和非小细胞肺癌（NSCLC）。基于FDA的Enhertu对2期试验DESTINY-PanTumor02的结果进行了肿瘤不可知论批准，该试验研究了HER2阳性肿瘤患者，包括胆道，膀胱，宫颈，子宫内膜，卵巢，胰腺或其他肿瘤。

In the study, patients on Enhertu experienced an overall response rate of 51% and a median duration of response of 19.4 months, according to AstraZeneca’s press release.AZ and Daiichi also examined the effect of Enhertu on patients with confirmed HER2-positive NSCLC and centrally confirmed HER2-positive colorectal cancer in the respective DESTINY-Lung01 and DESTINY-CRC02 trials.Enher.

根据阿斯利康的新闻稿，在这项研究中，Enhertu患者的总体缓解率为51%，中位缓解时间为19.4个月。AZ和Daiichi还在各自的DESTINY-Lung01和DESTINY-CRC02试验中检查了Enhertu对确诊的HER2阳性NSCLC患者和中心确诊的HER2阳性结直肠癌患者的影响。恩赫。