In development
As of 2023, Spectrum has one FDA approved drug (ROLVEDON™ (eflapegrastim) is also formerly known as Rolontis) and one drug in advanced development (Poziotinib).
Key Events for Rolvedon
On September 9, 2022, FDA approved ROLVEDON™ (formerly known as Rolontis)(eflapegrastim-xnst) injection indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
Development timeline for Rolvedon:
Sep 9, 2022 Spectrum announced FDA Approval of Rolvedon (eflapegrastim-xnst) Injection to Decrease the Incidence of Chemotherapy-Induced Neutropenia
April 11, 2022 FDA announced acceptance of Spectrum's re-submission of its Rolontis Biologics License Application (BLA)to FDA.
Aug 6, 2021 Spectrum received a Complete Response Letter (CRL) from FDA for Rolontis (eflapegrastim). FDA cited to manufacturing deficiencies that required the manufacturing facilities to be re-inspected by FDA.
Oct. 24, 2019 Spectrum re-submitted an updated version of its Biologics License Application (BLA)for ROLONTIS (eflapegrastim) to FDA based on 643 early-stage breast cancer patients. This BLA version included additional information in the Chemistry, Manufacturing and Controls (CMC) section.
Mar 18, 2019 After receiving FDA's request for additional (CMC) chemistry-manufacturing-control related information for Rolontis (eflapegrastim), Spectrum voluntarily withdrew its 2018 Biologics License Application (BLA) from FDA as more than 60 days time would have beenneeded to provide the additional CMC-related information FDA required before March 29, 2019, the end date of FDA's initial 60-day review period.
Dec 27, 2018 Spectrum announced its submission of the Biologics License Application to the FDA for Rolontis (eflapegrastim) as a Treatment for Chemotherapy-Induced Neutropenia based on 643 early-stage breast cancer patients.
Key Research and Development Events for Poziotinib
Poziotinib is a tyrosine kinase inhibitor in development for use in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations.
Nov 28, 2022 Spectrum announced the lay off 75% of R&D staff after FDA New Drug Application (NDA) rejection. Spectrum also announced plans to discontinue development of poziotinib, and to explore “strategic alternatives” for the Poziotinib program.
Nov 25, 2022 Spectrum received a Complete Response Letter from FDA for Poziotinib.
Sep 22, 2022 Spectrum provided an update on Poziotinib following the FDA Oncologic Drugs Advisory Committee (ODAC) Meeting regarding Spectrum's New Drug Application (NDA).
The ODAC voted 9–4 against a Poziotinib approval as the advisers judged the drug's risks outweighed its benefits.
Feb 11, 2022 Spectrum announced FDA acceptance of the New Drug Application (NDA) submitted for Poziotinib
Dec 6, 2021 Spectrum submitted the New Drug Application (NDA) for Poziotinib.
Mar 11, 2021 FDA Grants Fast Track Designation (FTD) to Spectrum for Poziotinib.
Dec 19, 2018 Spectrum announced that based on a subset of data from MD Anderson's ongoing Phase 2 study, FDA did not grant Breakthrough Therapy Designation (BTD) to Poziotinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 20 mutations.
Spectrum's BTD application included data from 30 patients from MD Anderson's Phase 2 study who had failed platinum-based chemotherapy.
