checkAd

Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)

Nachrichtenquelle: Business Wire (engl.)
23.07.2021, 22:30  |  153   |   |   

Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.

The complete response letter states that the FDA cannot approve the application in its present form. Consistent with the Oncologic Drugs Advisory Committee recommendation on June 24, 2021, the FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlimab for the treatment of patients with advanced or metastatic SCAC. Incyte is reviewing the letter and will discuss next steps with the FDA.

“Patients with SCAC who have progressed after first-line chemotherapy currently do not have approved treatment options,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “While we are not surprised with the FDA decision given the ODAC recommendation, we are disappointed. We remain committed to advancing science to find solutions for patients with unmet medical needs, and we will ensure close coordination with the FDA in order to address feedback and determine next steps for the review of retifanlimab.”

The BLA submission was based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or were ineligible for or intolerant of, platinum-based chemotherapy.

About Retifanlimab

Retifanlimab (formerly INCMGA0012), an investigational intravenous PD-1 inhibitor, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

Seite 1 von 2
Incyte Aktie jetzt über den Testsieger (Finanztest 11/2020) handeln, ab 0 € auf Smartbroker.de



Wertpapier



0 Kommentare

Schreibe Deinen Kommentar

Bitte melden Sie sich an, um zu kommentieren. Anmelden | Registrieren

 

Disclaimer

Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the …

Nachrichten des Autors

Titel
Titel
Titel
Titel

Nachrichten zu den Werten

DatumTitel
27.09.21Biotech Report: BioFrontera (B8F) und MorphoSys (MOR) legen zu; Evotec (EVT) konsolidieren
Shareribs | Weitere Nachrichten
25.09.21Chartgalerie - Top / Flop Aktien Wochenrückblick Kalenderwoche 38/21
w:o Chartvergleich | Chartanalysen
23.09.21Biotech Report: Biontech (22UA) und MorphoSys (MOR) legen zu; Analyst sieht Aufwärtspotential bei Sernova (PSH)
Shareribs | Weitere Nachrichten
22.09.21Incyte Announces FDA Approval of Jakafi (ruxolitinib) for Treatment of Chronic Graft-Versus-Host Disease (GVHD)
Business Wire (engl.) | Weitere Nachrichten
21.09.21Incyte Announces U.S. FDA Approval of Opzelura (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)
Business Wire (engl.) | Weitere Nachrichten
21.09.21Biotech Report: BioFrontera (B8F), Biontech (22UA) und Evotec (EVT) legen zu
Shareribs | Weitere Nachrichten
18.09.21Chartgalerie - Top / Flop Aktien Wochenrückblick Kalenderwoche 37/21
w:o Chartvergleich | Chartanalysen
14.09.21Incyte: Daten zu Ruxolitinib-Creme werden auf virtuellem Kongress der Europäischen Akademie für Dermatologie und Venerologie EADV 2021 präsentiert
Business Wire (dt.) | Weitere Nachrichten
13.09.21Incyte Announces Ruxolitinib Cream Data Accepted for Presentation at the 2021 European Academy of Dermatology and Venereology (EADV) Virtual Congress
Business Wire (engl.) | Weitere Nachrichten
13.09.21Biotech Report: Biontech (22UA) und Evotec (EVT) legen zu, MorphoSys (MOR) konsolidieren
Shareribs | Weitere Nachrichten