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Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

PARIS, FRANCE, 27 FEBRUARY 2026 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii

Ipsen receives positive CHMP opinion for Ojemda® for the treatment as monotherapy of children with relapsed or refractory BRAF-altered pediatric low-grade glioma

Fri, 27 Feb 2026 06:20:00 +0000

If approved, Ojemda® (tovorafenib) is expected to be the first and only targeted medicine in European Union for children with relapsed or refractory BRAF-altered pediatric low-grade glioma, irrespective of the type of BRAF alterationi
The decision is based on data from the pivotal Phase II FIREFLY-1 study which demonstrated clinically meaningful and durable tumor responses with a positive impact on children’s livesii