Spectrum Pharmaceuticals will lay off 75% of its research and development staff following the Food and Drug Administration’s rejection of the company’s cancer drug candidate poziotinib.
The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.
Spectrum Pharmaceuticals, Hanmi Pharmaceutical’s U.S. partner, said on Friday that it received a Complete Response Letter (CRL) from the FDA stating that the regulator needs supplementary data to approve poziotinib, a lung cancer treatment.
BOSTON--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI) (“Spectrum” or the “Company”), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration’s (“FDA”) Oncologic Drugs Advisory Committee (“ODAC”) met to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer (“NSCLC”) harboring HER2 exon 20 insertion mutations. The committee voted 9-4 that the current benefits of poziotinib did not outweigh its risks.
Sept 20 (Reuters) - The U.S. Food and Drug Administration's (FDA) staff on Tuesday raised concerns over the safety of Spectrum Pharmaceutical's (SPPI.O) experimental cancer drug and questioned the benefits it provided over existing therapies, dragging its shares 30%.
BOSTON--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced data from a poster presentation titled: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Cell Lung Cancer (NSCLC). The data show that poziotinib is highly active in G778 mutations in both treatment naïve and previously treated patients with NSCLC.
BOSTON--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a poster presentation titled: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Lung Cancer (NSCLC). The poster will be presented at the upcoming European Society for Medical Oncology Congress (ESMO) 2022 that will take place in Paris from September 9-13, 2022.
Hanmi Pharmaceutical said it would begin a local phase 3 trial of poziotinib to treat a certain type of non-small cell lung cancer (NSCLC). Attention is on whether the drugmaker will complete the confirmatory trial, a condition required by the U.S. FDA to obtain marketing approval.
Spectrum Pharmas Reports Second Quarter 2022 Financial Results
HENDERSON, Nev.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced the presentation of safety and efficacy results from Cohort 4 of the ZENITH20 clinical trial. This data is from 70 first-line patients with non-small lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16 mg daily, given as 16 mg once daily (48 patients) or 8 mg twice daily (22 patients) of oral poziotinib. These results showed a confirmed objective response rate (ORR) of 41% (95% CI:30%-54%), as evaluated centrally by an independent image review committee using RECIST 1.1 criteria. The evaluable patient population showed an ORR of 50%. The study met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%. The safety profile was consistent with the TKI class. The data is part of an oral presentation at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2022 being held virtually March 7-8, 2022.