Eli Lilly announces Alimta label expanded by FDA
Eli Lilly (LLY) announced that the FDA has granted approval for a new indication for Alimta in combination with carboplatin and Keytruda for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer, or NSCLC, irrespective of PD-L1 expression status.
Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival, or PFS.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merck (MRK) received accelerated approval for the combination of pembrolizumab with Alimta and carboplatin in May 2017.
This is the first and only combination of chemotherapy and immunotherapy to earn FDA approval for the first-line treatment of metastatic nonsquamous NSCLC.
This indication, now included in the Alimta prescribing information, is based on data from Merck’s KEYNOTE-021 study, Cohort G1.
The KEYNOTE-021, Part 2, Cohort G1, study included 123 previously untreated patients with locally advanced or metastatic nonsquamous NSCLC with no epidermal growth factor receptor, or EGFR, or anaplastic lymphoma kinase, or ALK, genomic tumor aberrations and irrespective of PD-L1 expression status.
The triplet combination of Alimta and carboplatin with pembrolizumab demonstrated a statistically significant improvement in objective response rate, or ORR, versus Alimta plus carboplatin alone and PFS.
Median PFS was 13 months for triplet and 8.9 months for Alimta plus carboplatin.
LLY closed at $85.07.
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