Pemigatinib by Incyte for Squamous Non-Small Cell Lung Cancer: Likelihood of Approval

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Pemigatinib overview

Pemigatinib (Pemazyre) is acts as an anti neoplastic agent. It is formulated as tablets for oral route of administration. Pemazyre is indicated for adults with certain types of previously treated, locally advanced or metastatic cholangiocarcinaoma and myeloproliferative disorder with with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

Pemigatinib (INCB-54828) is under development for the treatment of newly diagnosed acute myeloid leukemia, cholangiocarcinoma, gastric cancer, adenocarcinoma of the gastroesophageal junction, non-muscle invasive bladder cancer, metastatic or unresectable urothelial carcinoma, advanced malignancies such as solid tumors including squamous non-small cell lung cancer, gastric cancer, gastroesophageal junction carcinoma, bile duct cancer, urothelial carcinoma, breast/endometrial cancer, myeloproliferative neoplasms (myeloid/lymphoid neoplasms),  bladder cancer, colorectal cancer, recurrent glioblastoma, astrocytoma, esophageal carcinoma. It is a small molecule administered orally in the form of tablet. It targets FGFR1, FGFR2 and FGFR3 kinases.

It was also under development for the treatment of metastatic or surgically unresectable adeno squamous carcinoma of the pancreas, urothelial carcinoma as first line therapy, multiple myeloma and  oligodendroglioma, pilocytic astrocytoma.

Incyte overview

Incyte is a biopharmaceutical company, which discovers, develops and commercializes proprietary cancer therapeutics. The company’s lead product, Jakafi (ruxolitinib) is marketed in the US for the treatment of patients with high-risk myelofibrosis; and polycythemia vera who are intolerant to hydroxyurea. The company distributes Jakafi through a network of specialty pharmacy providers and wholesalers. In collaboration with Incyte, Novartis International Pharmaceutical Ltd (Novartis) develops and commercializes ruxolitinib outside the US for hematologic and cancer indications under the name Jakavi. The company’s pipeline portfolio encompasses drugs for the treatment of lung cancer, graft versus host disease, b-cell malignancies, solid tumors, non-small cell lung cancer, glioblastoma, liver cancer, and advanced malignancies. Incyte is headquartered in Wilmington, Delaware, the US.

For a complete picture of Pemigatinib’s drug-specific PTSR and LoA scores, buy the report here.

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.