Regulatory Focus™ > News Articles > 2019 > 9 > FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

Posted 17 September 2019 | By Zachary Brennan 

FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

The US Food and Drug Administration (FDA) on Tuesday unveiled a new initiative whereby its Oncology Center of Excellence (OCE) will work to approve new cancer drugs alongside Australia’s Therapeutic Goods Administration (TGA) and Health Canada.

The collaboration, dubbed Project Orbis, was launched with FDA’s decision with TGA and Health Canada to grant accelerated approval to Eisai's Lenvima (lenvatinib) in combination with Merck's Keytruda (pembrolizumab) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.

All three regulators said they collaboratively worked to review the application, which allows for simultaneous decisions in all three countries, although the labels in each country will differ.

“The aim of this collaborative review was to identify any regulatory divergence across the review teams,” OCE said.

Lenvima was initially approved by FDA in 2015 and Keytruda was initially approved in 2014. The combination treatment was approved via OCE’s Real-Time Oncology Review pilot program, which speeds up the submission of data prior to the completion and submission of the entire clinical application, and via its Assessment Aid.

Acting FDA Commissioner Ned Sharpless said in a statement that the three regulators “look forward to welcoming additional international partners to collaborate with us in this important initiative as we work to help further serve the global patient community.”

Australia and Canada previously worked together to approve two other cancer drugs — Eli Lilly’s Verzenio (abemaciclib) in April for the treatment of metastatic breast cancer and the July 2018 approval for Janssen’s prostate cancer treatment apalutamide.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe