FDA approves new Alimta indication
Eli Lilly's Alimta has a new indication. The company has received the Food and Drug Administration’s clearance for a new indication for Alimta (pemetrexed for injection) in combination with Merck’s Keytruda (pembrolizumab), and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, or NSCLC with no EGFR or ALK genomic tumor aberrations.
Alimta in combination with pembrolizumab and carboplatin was first approved in June 2018 under the FDA's accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC.
Alimta is a folate analog metabolic inhibitor indicated for the following: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations; in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, NSCLC; as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy; and as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
"Keynote-189 demonstrated an exceptional effect of the Alimta-pembrolizumab-platinum chemotherapy combination in the first-line setting, offering significantly improved survival in patients with metastatic nonsquamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations," Lilly oncology president Anne White, said. "This new indication reinforces Lilly's continued commitment to providing practice-changing treatment options that can make a meaningful difference for people living with lung cancer."
Alimta in combination with pembrolizumab and carboplatin was first approved in June 2018 under the FDA's accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC.
Alimta is a folate analog metabolic inhibitor indicated for the following: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations; in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, NSCLC; as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy; and as a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
"Keynote-189 demonstrated an exceptional effect of the Alimta-pembrolizumab-platinum chemotherapy combination in the first-line setting, offering significantly improved survival in patients with metastatic nonsquamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations," Lilly oncology president Anne White, said. "This new indication reinforces Lilly's continued commitment to providing practice-changing treatment options that can make a meaningful difference for people living with lung cancer."