AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients. Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy. That makes Enhertu the first HER-targeting drug for patients with HER2-mutant metastatic NSCLC, according to AstraZeneca and Daiichi Sankyo. Bob Li “After two decades of research into the role of targeting HER2 in lung cancer, the approval of the first HER2-directed treatment option validates HER2 as an actionable target in lung cancer and marks an important step forward for treating this patient population with unmet medical needs,” Bob Li, a medical oncologist at Memorial Sloan Kettering Cancer Center, said in a news release. The approval was based on data from the Phase II DESTINY-Lung02 trial, in which patients on Enhertu saw a confirmed objective response rate of 57.7% at an interim analysis, according to the partners. Complete responses were seen in 1.9% of patients and partial responses in 55.8% of patients, with a median duration of response of 8.7 months (95% CI 7.1-NE). Since the drug received an accelerated approval, researchers still need to show clinical benefit in a confirmatory trial. The news comes days after Enhertu won a quick approval in certain HER2-low breast cancer patients who’ve already failed chemotherapy, becoming the first therapy approved for patients who are part of a newly defined subset of HER-2 negative breast cancer patients, according to the FDA. That approval came less than two weeks after the drug’s sBLA was accepted, months ahead of its Q4 PDUFA date. This May, Enhertu was also approved as a second-line treatment for advanced HER2-positive breast cancer, expanding upon its original 2019 approval into an earlier treatment setting. In addition to the two breast cancer setting approvals, Enhertu is also approved for metastatic HER2-positive gastric cancer. Enhertu’s original metastatic breast cancer thumbs-up has also been converted from accelerated approval to full approval, AstraZeneca said. The drug is now approved in three total indications as sales numbers only continue to grow, with Enhertu racking up $397 million in global sales, excluding Japan, in the first half of 2022. Last year, global sales of Enhertu, excluding Japan, amounted to $426 million. And AstraZeneca is waiting on data on Enhertu as a 3rd-line treatment for HER2+ breast cancer, and other trials related to gastric cancer and NSCLC, according to AstraZeneca’s last annual report. MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones. More