Pemazyre (Pemigatinib) 4.5/9/13.5mg | Incyte USA Originator | GLT

Generic Information: Pemazyre (Pemigatinib) — United States

Pemazyre is the originator brand of pemigatinib, discovered and developed by Incyte Corporation of the United States. It was the first targeted therapy approved by the FDA for cholangiocarcinoma, receiving accelerated approval as a treatment for adults with previously treated, locally advanced or metastatic bile duct cancer harbouring an FGFR2 fusion or other rearrangement. This listing is the US presentation, offered in three tablet strengths — 4.5 mg, 9 mg and 13.5 mg — each in a 14-tablet pack that matches the standard 13.5 mg once-daily dosing schedule of 14 days on followed by 7 days off.

Pemazyre's approval rests on the FIGHT-202 study, which demonstrated a meaningful objective response rate in FGFR2-altered cholangiocarcinoma, a disease with very limited treatment options. Because it was granted accelerated approval, the US indication is confirmed by a companion diagnostic test for FGFR2 status. Buyers should confirm the specific strength and pack size they require, as the three presentations are used across dose escalation and maintenance.

What Is Pemazyre Used For?

Pemazyre treats adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma — cancer of the bile ducts — whose tumour carries an FGFR2 fusion or rearrangement, as detected by an approved diagnostic test. Cholangiocarcinoma is a rare and aggressive malignancy that is often diagnosed late, and FGFR2 alterations occur in a subset of intrahepatic cases. Pemazyre provides the first oral, targeted option specifically for this molecularly defined group.

How Does Pemazyre Work?

Pemigatinib is a small-molecule inhibitor of fibroblast growth factor receptor (FGFR) 1, 2 and 3. In tumours with an FGFR2 fusion or rearrangement, the receptor is constitutively activated and drives uncontrolled cell growth. By blocking FGFR signalling, Pemazyre disrupts the proliferative and survival signals that depend on these receptors. It also reduces the viability of cells that carry FGFR gene alterations, including point mutations and amplifications.

Indications

• Previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, confirmed by an FDA-approved test.
• Adult patients whose disease has progressed after at least one prior line of systemic therapy.

Dosage and Administration

The recommended starting dose is 13.5 mg once daily for 14 consecutive days, followed by 7 days off therapy, repeating this 21-day cycle. Tablets are taken orally with or without food and swallowed whole. The 4.5 mg and 9 mg strengths support dose modifications where needed. Regular monitoring of phosphate levels, renal function and eye health is advised, as hyperphosphatemia and retinal disorders are recognised effects.

Side Effects

Common adverse reactions include hyperphosphatemia, diarrhoea, stomatitis, dry mouth, fatigue, nausea and alopecia. Pemazyre carries a boxed warning for the risk of serous retinal detachment, so patients should have ophthalmologic evaluation and report visual changes promptly. Other notable effects include dry eye, nail changes and elevated liver enzymes.

Storage

Store Pemazyre at room temperature, below 25°C, in the original package, away from moisture and out of the reach of children. Use before the expiry date printed on the pack.

Why Choose the GLT?

GLT can source the originator Pemazyre and its regional presentations for buyers who specifically require the Incyte brand, with documentation for import and compliance. The US list price of Pemazyre is high — several thousand dollars per 21-day cycle at launch — so GLT helps institutions and patients identify the most cost-effective compliant supply route, and provides clear, responsive ordering support from inquiry through delivery.

How to Order Pemazyre from GLT

Contact GLT on WhatsApp at +86 15234153837 or email [email protected] to inquire about Pemazyre. Specify the strength you need (4.5 mg, 9 mg or 13.5 mg), your quantity and destination. We confirm pricing, batch origin and the required export documentation before dispatch.

FAQ

Is Pemazyre the original pemigatinib? Yes, Pemazyre is the originator brand developed by Incyte Corporation; all other pemigatinib products are generics of it.

What does Pemazyre treat? It treats cholangiocarcinoma (bile duct cancer) with an FGFR2 fusion or rearrangement in adults who have already received treatment.

What is the dosing schedule? 13.5 mg once daily for 14 days, then 7 days off, repeated in 21-day cycles.