Onco-Summaries: Daily Oncology Updates at a Glance

30/03/2026

---

• Zymeworks' ZW191 ADC received the FDA fast track designation for PROC

• Elevar Therapeutics' NDA for lirafugratinib received priority review status from the FDA for cholangiocarcinoma

---

Zymeworks' ZW191 ADC received the FDA fast track designation for PROC (Ref)

The US FDA granted the fast track designation to Zymeworks Inc's ZW191 (FRα-targeting ADC) for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC).

• Zymeworks is currently evaluating ZW191 in a Phase 1 clinical study (NCT06555744)

• Sabeen Mekan, Senior Vice President and Chief Medical Officer, Zymeworks: “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 FRα expression highlighting ZW191’s potential of extending treatment benefits to a broad group of patients without need for biomarker selection. This designation also further reinforces our expertise in ADC development, and we look forward to working closely with the FDA to advance this program for patients with difficult-to-treat cancers.”

  
  

Return to Top

Elevar Therapeutics' NDA for lirafugratinib received priority review status from the FDA for cholangiocarcinoma (Ref)

The US FDA accepted the NDA and granted priority review status to Elevar Therapeutics Inc's lirafugratinib (FGFR2 inhibitor) for the treatment of patients with cholangiocarcinoma with FGFR2 fusions or rearrangements who have received prior therapy.

• A PDUFA target action date of September 27, 2026 has been set

• The designation was supported by positive clinical data from the Phase 1/2 ReFocus trial (NCT04526106)

Return to Top