Tovorafenib (Ojemda) is a precision cancer therapy known as a pan-RAF inhibitor. This article is about its uses in cancer, side effects, dosage.

FDA has granted an accelerated approval to tovorafenib (Ojemda) for kids and teens who have low-grade glioma with changes in the BRAF gene.

Ojemda addresses unmet need for patients aged 6 months and older with paediatric brain tumour with BRAF alterations

On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months

The European Commission has published its inaugural Joint Clinical Assessment (JCA), officially activating the EU’s modernized Health Technology Assessment (HTA) framework under Regulation (EU) 2021/2...

The European Commission has published its inaugural Joint Clinical Assessment (JCA), officially activating the EU’s modernized Health Technology Assessment (HTA) framework under Regulation (EU) 2021/2...

The European Commission has published its inaugural Joint Clinical Assessment (JCA), officially activating the EU’s modernized Health Technology Assessment (HTA) framework under Regulation (EU) 2021/2...

Ligand (Nasdaq: LGND) completed its acquisition of biotechnology royalty aggregator XOMA Royalty for $39.00 per share in cash, implying total equity value of approximately $739 million. XOMA Royalty stockholders also received one non-transferable contingent value right (CVR) per share, tied to 75% of net proceeds from certain pending litigation at XOMA Royalty.According to Ligand, the deal adds seven commercial products, including VABYSMO, OJEMDA and MIPLYFFA, plus 14 late-stage programs and more than 100 additional development and commercial-stage assets. Ligand’s royalty portfolio now exceeds 200 assets across commercial, clinical and preclinical stages. The transaction closed on the original timeline and is expected to be immediately accretive, adding about $0.50 and $1.50 per share to projected 2026 and 2027 adjusted EPS, respectively. Ligand plans to provide an updated five-year outlook at its Investor Day on December 8, 2026. XOMA Royalty common stock has ceased trading on the Nasdaq Global Market.

The FoundationOne test can be used to identify patients with relapsed or refractory BRAF-altered pediatric low-grade glioma who may be eligible for therapeutic options.

The European Commission has granted conditional marketing authorization for Ojemda (tovorafenib) as monotherapy for the treatment of patients 6 months of age and older with pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies. To access this subscriber-only content please log in […]

Par AFP © 2026 AFP Le groupe pharmaceutique français Ipsen a annoncé mercredi avoir obtenu une "autorisation de mise sur le marché conditionnelle" dans l'Union européenne pour sa thérapie Ojemda utilisée dans une tumeur cérébrale rare de l'enfant. "La Commission européenne a accordé une autorisation de mise sur le marché conditionnelle à Ojemda (tovorafénib)", pour les patients âgés de 6 mois et plus atteints d’un gliome pédiatrique à progression lente, en rechute ou en progression malgré d'autres traitements, selon un communiqué. L'autorisation actuelle est accordée sur la base de données cliniques prometteuses mais encore incomplètes. Le laboratoire devra démontrer de manière définitive le bénéfice clinique du tovorafénib via des études supplémentaires. Il avait acquis les droits du tovorafénib hors Etats-Unis en 2024 auprès de Day One Biopharmaceuticals. "Notre priorité est désormais de garantir un accès aussi rapide que possible à ce traitement pour les enfants éligibles dans toute l’Europe", indique Ipsen, soulignant que "moins de 10% des nouvelles autorisations de médicaments au cours des cinq dernières années ont porté sur des maladies pédiatriques". Chaque année dans l'Union européenne, plus de 800 enfants sont diagnostiqués avec un gliome pédiatrique de bas grade présentant une altération génétique (celle de BRAF). Cette tumeur cérébrale entraîne fréquemment des déficiences physiques et neurologiques sévères, notamment une perte de la vision, des troubles de l’élocution et des dysfonctions motrices, qui peuvent fortement affecter la scolarité, l’autonomie et la qualité de vie à long terme, décrit le laboratoire. Jusqu’à présent, de nombreux enfants atteints devaient subir des opérations lourdes et des traitements par chimiothérapie et radiothérapie.

Servier has made a takeover offer for Day One and its fast-growing glioma therapy Ojemda, as it pitches to drive sales above €10bn by 2030.

New treatment option for rare, life-altering pediatric brain tumors  Less than 10% of new medicine approvals over the past five years have focused on pediatric dise…

Day One Biopharmaceuticals is Servier’s biggest acquisition yet, topping the $2.4 billion it paid to buy Shire’s cancer business in 2018. Day One markets Ojemda, approved for treating pediatric low-grade glioma, the most common type of brain cancer in children.

How FIREFLY1 data positioned Ipsen’s Ojemda for conditional EU approval in pediatric glioma and what it means for investors and competitors.