Knight Therapeutics Announces Regulatory Submission of Pemigatinib in Brazil

MONTREAL, Oct. 10, 2023 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Brazilian affiliate, United Medical Ltd., has submitted a marketing authorization application for pemigatinib to ANVISA, the Brazilian health regulatory agency, under the rare diseases approval pathway, for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Marketing authorization applications for pemigatinib have also been submitted previously in Colombia, Mexico and Argentina.

“This milestone demonstrates Knight’s commitment to providing innovative therapies for important unmet healthcare needs in Latin America,” said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

Cholangiocarcinoma is the malignant neoplasm of the primary biliary tract, being the intrahepatic type localized in the biliary duct ramifications inside the liver. This kind of tumor is considered rare, and more than 50% of the patients are diagnosed in advanced disease stages.

In September 2021, Knight entered into a supply and distribution agreement with Incyte (NASDAQ: INCY), for the exclusive rights to distribute pemigatinib (Pemazyre^®) as well as tafasitamab (sold as Monjuvi^® in the United States and Minjuvi^® in Europe) in Latin America.

In July 2023, ANVISA granted regulatory approval in Brazil for Minjuvi^® in combination with lenalidomide followed by tafasitamab monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL due to low-grade lymphoma, who are not eligible for autologous stem cell transplantation (ASCT). Upon obtaining the marketing authorization from ANVISA, Knight submitted an application for pricing approval to the Drugs Market Regulation Chamber (“CMED”) which establishes maximum prices allowed for drugs sold in Brazil. The commercial launch of Minjuvi^® is dependent upon the outcome of the pricing approval process which could take up to two years. Knight has also submitted marketing authorization applications for tafasitamab in Colombia, Mexico and Argentina.

About Pemigatinib (Pemazyre^®)

Pemigatinib is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The FDA approval in the USA is based on a multicenter, open-label, single-arm, multicohort, phase 2 study (FIGHT-202), that evaluated the safety and antitumor activity of pemigatinib in patients with previously treated, locally advanced or metastatic intrahepatic cholangiocarcinoma with and without FGFR2 fusions or rearrangements, in patients aged 18 years or older with disease progression following at least one previous treatment.

The overall response rate was 36%, with 2.8% of patients having a complete response and 34% having a partial response. Median duration of response was 9.1 months. The most common adverse reactions occurring in 20% or more of patients who received pemigatinib are hyperphosphatemia, alopecia, diarrhea, fatigue, dysgeusia, nausea and stomatitis.

Pemigatinib is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement.

In Japan, pemigatinib is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

In Europe, pemigatinib is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre^® is marketed by Incyte in the United States, Europe and Japan.

Pemazyre^® is a trademark of Incyte Corporation.

About Tafasitamab (Minjuvi^®)

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb^® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi^® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplantation (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Please see the U.S. full Prescribing Information for Monjuvi for important safety information. 

In Europe, Minjuvi^® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Its safety and efficacy for these investigational uses have not been established in pivotal trials.

Minjuvi^® and Monjuvi^® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi^® in the U.S., and marketed by Incyte under the brand name Minjuvi^® in Region Europe, the United Kingdom and Canada. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States.

XmAb^® is a registered trademark of Xencor, Inc.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight’s Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedar.com.

Forward-Looking Statement

This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2022, as filed on www.sedar.com. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.

References

K Abou-Alfa et al. (2020). Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. The Lancet Oncology VOLUME 21, ISSUE 5, P671-684, MAY 2020. DOI:https://doi.org/10.1016/S1470-2045(20)30109-1

Banales, J., Cardinale, V., Carpino, G. et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol 13, 261–280 (2016). https://doi.org/10.1038/nrgastro.2016.51