The US Food and Drug Administration (FDA) has approved Enhertu, a breast cancer drug AstraZeneca PLC (LON:AZN) and Japan's Daiichi Sankyo are jointly developing and commercialising.
The FDA has approved Enhertu – or fam-trastuzumab deruxtecan-nxki – for the treatment of adult patients with breast cancer where surgical removal of the affected area is not an option or where the cancer is in a fast-growth (metastatic) phase, and who have received two or more prior anti-HER2 (human epidermal growth factor) based regimens in the metastatic setting.
In a statement, AstraZeneca said this indication from the FDA is approved under Accelerated Approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
AstraZeneca and Daiichi Sankyo are exploring the further potential of Enhertu in HER2-breast cancer with three ongoing Phase III trials.
Following US approval, AstraZeneca is obliged to pay US$125mln to Daiichi Sankyo as the first milestone payment in HER2-positive breast cancer.
Future sales of Enhertu in the US will be recognised by Daiichi Sankyo. AstraZeneca will report its share of gross profit margin from the sales in the US as collaboration revenue in the company's financial statements.
"Enhertu has shown impressive results in women with HER2-positive metastatic breast cancer, with the majority of women benefiting from treatment and the median duration of the response exceeding 14 months. With this first approval, we are proud to bring Enhertu to patients with high unmet need and we look forward to further exploring its potential in additional settings,” said José Basel, the executive vice president of oncology research & development (R&D) at AstraZeneca.
Antoine Yver, the executive vice president and global head of Oncology R&D at Daiichi Sankyo said the company is “extremely proud of how quickly we delivered Enhertu to patients in the US”.
“The approval of Enhertu underscores that this specifically engineered HER2-directed antibody-drug conjugate is delivering on its intent to establish an important new treatment for patients with HER2-positive metastatic breast cancer,” Yver said.
China COPD treatment approval
In a separate statement on Monday, AstraZeneca also announced that budesonide/glycopyrronium/formoterol fumarate has been approved in China for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
This is the first approval by the National Medical Products Administration for a triple-combination therapy in a pressurised metered-dose inhaler (pMDI), which uses the innovative Aerosphere delivery technology.
The FTSE 100-listed company said the approval follows a priority review and is based on results from the Phase III KRONOS trial in which PT010 demonstrated a statistically significant improvement in trough forced expiratory volume in one second (FEV1), the primary endpoint for China, compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).