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FDA approves first new drug under Project Orbis

Posted 17 April 2020 | By Michael Mezher 

FDA approves first new drug under Project Orbis

The US Food and Drug Administration (FDA) on Friday approved the first new molecular entity as part of an international collaborative review effort dubbed Project Orbis.
The drug, Seattle Genetics’ Tukysa (tucatinib) was approved in combination with chemotherapy drugs trastuzumab and capecitabine to treat adult patients with inoperable or metastasized advanced HER2-positive breast cancer who have received prior treatments.
Launched last year, Project Orbis is a collaborative review effort for oncology products that includes FDA, Australia’s Therapeutic Goods Administration (TGA), Health Canada, Singapore’s Health Sciences Authority (HSA) and Swissmedic. (RELATED: FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs, Regulatory Focus 17 September 2020; NASEM Committee Calls to Expand Agreements Between Drug Regulators, Regulatory Focus 21 November 2019).
While Tukysa is the first new drug approved by FDA under Project Orbis, it marks the third action taken by the agency as part of the collaboration and the first time HSA and Swissmedic participated in a review. FDA notes that while it has approved Tukysa, its application is still being reviewed by the other agencies.
In September, FDA, TGA and Health Canada simultaneously approved Eisai’s Lenvima (lenvatinib) and Merck’s Keytruda (pembrolizumab) to treat patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have received prior systemic therapy but are not candidates for surgery or radiation. In November, the three regulators approved a new indication for AstraZeneca’s Calcquence (acalabrutinib) to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
“In this critical time, we remain steadfast in our commitment to patients with cancer and doing everything we can to expedite oncology product development. Tukysa was approved four months prior to the FDA goal date, providing an example of this commitment and showing how our regular work in reviewing treatments for patients with cancer is moving forward without delay,” said OCE Director Richard Pazdur.
FDA adds that Tukysa was also reviewed under its real-time oncology review (RTOR) pilot and was granted priority review, breakthrough therapy, fast track and orphan designations.


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