Pemazyre

Oncology· 922 cited findings· 1 source document

What the regulatory reviews say

Pemazyre (pemigatinib) is indicated for the treatment of locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement, as detected by a validated test, in adults who have previously received at least one prior line of systemic therapy. The proposed dose of pemigatinib is 13.5 mg.

In Cohort A, which included patients with FGFR2 translocations with a documented fusion partner, the Objective Response Rate (ORR) was 35.5%, with a Complete Response (CR) rate of 2.8% and a Partial Response (PR) rate of 32.7%. The median Duration of Response (DOR) was 8.08 months. The 12-month Overall Survival (OS) in Cohort A was 67.5%, and the median Progression-Free Survival (PFS) was 6.93 months. In Cohort B and Cohort C, the Objective Response Rate (ORR) was 0%.

The most common treatment-emergent adverse event (TEAE) was hyperphosphatemia (69.0%). Grade 3+ TEAEs occurred in 56.9% of patients, and serious TEAEs occurred in 40.5% of patients. The mean duration of exposure to pemigatinib was 247.4 days. Pemazyre received an Orphan medicinal product designation (EU/3/18/2066) and a CHMP positive opinion for marketing authorisation on 28 January 2021, with a revised opinion adopted on 25 February 2021. The application type was for Conditional Marketing Authorisation.

Key figures — cited to the source page

Objective Response Rate (ORR)	35.5	Incyte Corporation — Pemazyre EMA EPAR public assessment rep, p.79
12-month OS in Cohort A	67.5	Incyte Corporation — Pemazyre EMA EPAR public assessment rep, p.86
Median Duration of Response (DOR)	8.08	Incyte Corporation — Pemazyre EMA EPAR public assessment rep, p.80
Median Progression-Free Survival (PFS) in Cohort A	6.93	Incyte Corporation — Pemazyre EMA EPAR public assessment rep, p.84
most common TEAE (hyperphosphatemia)	69.0	Incyte Corporation — Pemazyre EMA EPAR public assessment rep, p.67
Grade 3+ TEAEs	56.9	Incyte Corporation — Pemazyre EMA EPAR public assessment rep, p.67
CHMP positive opinion for marketing authorisation	28 January 2021	Incyte Corporation — Pemazyre EMA EPAR public assessment rep, p.11
Application type	Conditional Marketing Authorisation	Incyte Corporation — Pemazyre EMA EPAR public assessment rep, p.15

Source documents

Incyte Corporation — Pemazyre EMA EPAR public assessment report (EMEA/H/C/005266, 2021) (2021)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.