After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. approval in the cancer immunotherapy Anktiva.Anktiva, which is an interleukin-15 superagonist, is now cleared by the FDA alongside the Bacillus Calmette-Guérin (BCG) vaccine to treat patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS),  ImmunityBio said Monday.The drug will now compete with Merck & Co.’s PD-1 inhibitor Keytruda and Ferring Pharmaceuticals’ gene therapy Adstiladrin in the same NMIBC CIS setting regardless of the presence of papillary tumors.

在合并和FDA拒绝后，名人商人和生物技术企业家Patrick Soon Shiong的ImmunityBio获得了该公司在癌症免疫疗法Anktiva的首次美国批准。ImmunityBio周一表示，Anktiva是一种白细胞介素15超抗原学家，目前已被FDA与卡介苗（BCG）疫苗一起批准，用于治疗卡介苗无反应的非肌肉浸润性膀胱癌（NMIBC）原位癌（CIS）患者。该药物现在将与默克公司（Merck＆Co.）的PD-1抑制剂Keytruda和Ferring Pharmaceuticals的基因治疗Adstiladrin在相同的NMIBC顺式环境中竞争，无论是否存在乳头状肿瘤。

Both Anktiva and Adstiladrin are administered directly into the bladder, while Keytruda comes as an intravenous therapy.Pharma data intelligence outlet Evaluate recently listed Anktiva among the top 10 drug launches expected this year, pegging the immunotherapy could reach nearly $900 million in 2028 sales.Anktiva’s edge, to hear ImmunityBio’s executive chair Soon-Shiong and CEO Richard Adcock tell it, lies in its ability to induce “durable complete remission.”In cohort A of the pivotal QUILT-3.032 trial, 58 of 82 patients with high-risk, BCG-unresponsive NMIBC with CIS who took the Anktiva-BCG combo had no measurable tumors after a median follow-up of about two years.

Anktiva和Adstiladrin均直接注入膀胱，而Keytruda则作为静脉注射疗法。Pharma data intelligence outlet Evaluate最近将Anktiva列为今年预计推出的前十大药物之一，预计该免疫疗法在2028年的销售额可能达到近9亿美元。ImmunityBio执行主席Soon Shiong和首席执行官Richard Adcock告诉我们，Anktiva的优势在于其诱导“持久完全缓解”的能力。在关键的QUIST-3.032试验的队列A中，82名服用Anktiva-BCG组合的高危BCG无反应的CIS NMIBC患者中，有58名在中位随访约两年后没有可测量的肿瘤。

The complete response rate was therefore 71%, and the median duration of complete response was 26.6 months, according to data published in NEJM Evidence in late 2022.Despite the clinical data, the FDA in May 2023 rejected Anktiva, also known as N-803. The agency’s complete response letter cited deficiencies found during a pre-approval inspection at ImmunityBio’s third-party manufacturing contractor.

因此，根据2022年末NEJM证据中公布的数据，完全缓解率为71%，完全缓解的中位持续时间为26.6个月。尽管有临床数据，FDA于2023年5月拒绝了Anktiva，也称为N-803。该机构的完整回复信引用了在ImmunityBio的第三方制造承包商进行的预批准检查中发现的缺陷。

The FDA also provided recommendations related to add.

FDA还提供了与add相关的建议。