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AZ, Daiichi Sankyo’s Enhertu fast-tracked in US for NSCLC

HER2 inhibitor awarded breakthrough designation by FDA

Daiichi AZ alliance

AstraZeneca and Daiichi Sankyo’s Enhertu has won a breakthrough designation (BTD) from the US Food and Drug Administration (FDA) for metastatic HER2-positive non-small cell lung cancer (NSCLC).

AZ and Daiichi were awarded their first approval for Enhertu (trastuzumab deruxtecan) last December as a treatment for patients with metastatic HER2-positive breast cancer who had been previously treated with two or more anti-HER2 based regimens.

Enhertu is one of a crop of new HER2-targeting drugs that is aiming to challenge Roche’s long-dominant position, particularly in HER2-positive breast cancer, with its franchise of Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine).

Now, AZ and Daiichi are looking to broaden Enhertu’s horizons, and encroach onto the highly competitive NSCLC market, which is otherwise dominated by Merck/MSD’s PD-1 inhibitor Keytruda (pembrolizumab).

Despite Keytruda’s dominance, the HER2-positive subset within the wider NSCLC patient population could give Enhertu a significant niche to grow sales and strengthen its position among the HER2-targeting class.

The FDA’s BTD was based on data from the ongoing phase 2 DESTINY-Lung01 trial, with the interim analysis from this study due to be presented later this month at the American Society of Clinical Oncology (ASCO) virtual meeting currently taking place.

“We are encouraged by the promising evidence of activity seen with Enhertu in patients with advanced lung cancer and a HER2 mutation,” said Gilles Gallant, senior vice president, global head, oncology development, oncology R&D, Daiichi Sankyo. “

We look forward to working closely with the FDA on the potential for Enhertu to become the first HER2 directed therapy approved for non-small cell lung cancer.”

For AZ and Daiichi, the BTD in NSCLC rounds out a trio of such designations for Enhertu, with the drug also having gained an accelerated review in metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma this week.

It was also awarded a BTD, which led to the accelerated approval in December, in HER2-positive breast cancer.

AZ paid Daiichi an impressive $1.35bn upfront to license the drug last year, in a deal that could be worth up to $6.9bn if all development and sales milestones are met. Analysts have also forecast that Enhertu could reach peak sales of over $4bn each year, if it achieves approvals in its target markets.

According to Daiichi, there are currently six pivotal trials of Enhertu ongoing across the globe, in a range of HER2 cancers such as breast, gastric and lung cancers. Further trials of the HER2 inhibitor in combination with other anticancer treatments including immunotherapy treatments are also underway.

Article by
PMGroup

18th May 2020

From: Research

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