AstraZeneca: US Approves Enhertu, China Approves Triple-combination For COPD

British drug major AstraZeneca (AZN,AZN.L) and Japanese pharmaceutical company Daiichi Sankyo Co. Ltd. (DSKYF.PK) announced Monday that the US Food and Drug Administration has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens.

Following US approval, AstraZeneca will pay $125 million to Daiichi Sankyo as the first milestone payment in HER2-positive breast cancer. Upon approval, this will be capitalised together with the upfront payment already made earlier in the year 2019.

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.

The companies said the indication is approved under Accelerated Approval based on tumour response rate and duration of response. The companies noted that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The FDA approval is based on the results of the registrational Phase II trial DESTINY-Breast01 of Enhertu (5.4mg/kg) monotherapy in patients with HER2-positive metastatic breast cancer.

The companies noted that a regulatory submission for the treatment of patients with HER2-positive metastatic breast cancer has also been made to Japan's Ministry of Health, Labour and Welfare based on the DESTINY-Breast01 and Phase I trials.

AstraZeneca and Daiichi Sankyo are exploring the further potential of Enhertu in HER2-breast cancer with three ongoing Phase III trials.

Separately, AstraZeneca announced that its triple-combination therapy - budesonide/glycopyrronium/formoterol fumarate - has been approved in China for the maintenance treatment of chronic obstructive pulmonary disease or COPD. It is the first approval by the National Medical Products Administration for a fixed-dose triple-combination therapy in a pressurised metered-dose inhaler device in China.

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, the primary endpoint for China, compared with dual-combination therapies Bevespi Aerosphere and PT009.

Budesonide/glycopyrronium/formoterol fumarate was approved in Japan in June 2019 as Breztri Aerosphere, a triple-combination therapy to relieve symptoms of COPD. The medicine is also under regulatory review in the US and EU, under the name PT010.

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