With another FDA nod, Eagle's Pemfexy gets up to speed with Lilly's Alimta

After gaining a tentative FDA approval for Pemfexy in 2017, it took nearly five years for Eagle Pharmaceuticals to bring the chemotherapy to the market because of a patent squabble with Eli Lilly.

It finally became available in February of this year for non-squamous non-small cell lung cancer (NSCLC) and mesothelioma patients.

Now, the FDA has blessed Pemfexy with a fifth indication, this one as an initial combo treatment alongside Merck’s Keytruda and platinum chemotherapy for those with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

Pemfexy is a ready-to-dilute liquid intravenous formulation developed to eliminate the reconstitution step of Lilly’s blockbuster lung cancer therapy Alimta.

The other uses for Pemfexy are for locally advanced or metastatic non-squamous NSCLC in combination with cisplatin; as a maintenance treatment for locally advanced or metastatic non-squamous NSCLC that hasn’t progressed after four cycles of platinum-based chemo; for locally advanced or metastatic NSCLC after previous chemo as a single agent; and for certain patients with malignant pleural mesothelioma.

The five indications for Pemfexy now mirror those of Alimta, which was originally approved in 2004 and finally has been hit with generic competition this year, slicing sales to $228 million in the second quarter of this year and $119 million in the third quarter. Alimta’s sales were at $2.3 billion in 2016 and $1.2 billion in 2021.

New Jersey-based Eagle added Monday that it had amended its agreement with Lilly to reduce future royalties for Pemfexy profits from 25% to a range of between 0% and 12.5% in exchange for a one-time payment of $15 million. The amendment became effective on Oct. 1.