Hanmi’s US partner gives up poziotinib, shifts focus to Rolvedon

Hanmi Pharmaceutical's U.S. partner, Spectrum, said that they would “deprioritize” poziotinib, its lung cancer treatment candidate, after receiving a CRL (Complete Response Letter) from the U.S. FDA at 6 a.m. (KST: 9 p.m.) on Friday.

Poziotinib aims to treat non-small cell lung cancer (NSCLC) with locally advanced and metastatic HER2 Exon 20 insertion mutation, for which there is currently no suitable treatment.

However, Spectrum will immediately lower the priority of the poziotinib program activities and instead focus its resources on marketing and sales of the new biological drug Rolvedon (Korean product name: Rolontis) which was approved by the FDA in September this year.

Additionally, Spectrum said it would reduce its R&D workforce by 75 percent by the end of this year and use the anticipated cost savings on the commercialization of  Rolvedon.

Rolvedon targets adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with the incidence of febrile neutropenia and has an estimated market opportunity of approximately $2 billion (2.67 trillion won).

“While we are not surprised by the CRL given the Oncologic Drugs Advisory Committee (ODAC) recommendation in September, we are disappointed,” said Spectrum Pharmaceuticals CEO Tom Riga. "After following careful considerations from the FDA and ODAC, we made the strategic decision, to deprioritize the poziotinib program which we believe is in the best interest of the company and our shareholders."

Riga added, “We continue to believe that poziotinib could present a meaningful treatment option where other therapies have failed and are committed to exploring strategic alternatives including partnerships and business development opportunities to support patients."

He expressed gratitude to all the patients, their families, and clinicians for their dedication to the poziotinib program.

As of 10:15 AM on Monday, Hanmi’s shares stood at 251,500 won ($187.92), down 0.59 percent from the previous trading day.