Spectrum Pharmaceuticals received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its potential treatment, poziotinib.
The company had submitted a new drug application (NDA) for the drug candidate as a treatment for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC), harboring HER2 exon 20 insertion mutations.
The CRL stated that Spectrum would need to generate additional data, including a randomized controlled study, prior to reconsidering approval for poziotinib.
In a statement, CEO of Spectrum, Tom Riga, said, “While we are not surprised by the CRL given the ODAC recommendation in September, we are disappointed. After multiple interactions with the FDA since ODAC, and following careful consideration, we have made the strategic decision to immediately de-prioritize the poziotinib program.”
The ODAC (Oncologic Drugs Advisory Committee) meeting referred to was a review in September 2022 of the treatment. During the meeting, the committee voted nine to four in favour of the judgement that the drug candidate’s benefits did not outweigh its risks.
As a result, a final approval from the FDA was unlikely, as the agency usually follows the judgement of its advisory committee.
Spectrum announced that it would immediately de-prioritize further development of poziotinib, and that it would reduce R&D staff levels by approximately 75%.
The company stated that the aim behind cutting staff numbers would be to achieve cost savings, which would allow it to complete ‘strategic refocusing’ through to 2024.
The CRL, as well as being a blow to Spectrum, also had a knock-on impact for Hanmi Pharmaceuticals. The South Korean company is a licensing partner on poziotinib and had made an equity investment of $20m (€19.2m) in Spectrum as recently as January 2022.
On the news of the advisory committee’s recommendation on poziotinib in September 2022, the Korean company’s share price dropped by approximately 15%.
However, the two partners are also working together on Spectrum’s Rolvedon (eflapegrastim) product, which managed to secure approval for use in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
The treatment was approved by the FDA in September 2022, and Spectrum stated that it has “an estimated market opportunity of approximately $2bn.” Following the FDA’s CRL decision, the company stated that it would now focus its effort on driving growth for this product, which Spectrum stated it had launched shortly after FDA approval.