FDA Grants Fast Track Designation To Zymeworks' ZW191 For Platinum-Resistant Ovarian Cancer

(RTTNews) - Zymeworks Inc.'s (ZYME) investigational drug ZW191 has been granted Fast Track designation by the FDA for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer. Shares are up over 3% at $24.73 in premarket trading on Monday.

ZW191 is an antibody-drug conjugate (ADC) designed to target folate receptor (FR), a protein that is overexpressed across multiple tumor types, including approximately 75% of high-grade serous ovarian carcinomas, over 50% of endometrial cancers, and around 70% of lung adenocarcinomas.

The FDA's Fast Track designation is meant to speed up the development and review of drugs that could treat serious conditions, helping bring important new treatments to patients faster, especially where there are unmet medical needs.

A phase I trial of ZW191 in patients with advanced solid tumors is currently underway.

Commenting on the Fast Track designation, Sabeen Mekan, Senior Vice President and Chief Medical Officer at Zymeworks said, "Receiving Fast Track Designation for ZW191 highlights the potential of this program to address significant unmet medical needs for patients with previously treated advanced ovarian cancer. Notably, the designation was granted irrespective of FR expression, highlighting ZW191's potential of extending treatment benefits to a broad group of patients without the need for biomarker selection".

ZYME has traded in a range of $9.03 to $28.49 in the last 1 year. The stock closed Friday's trading at $24.18, down 2.07%.

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