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Chimerix’s Dordaviprone Receives FDA Priority Review for Recurrent H3 K27M-Mutant Diffuse Glioma

IntroductionChimerix, a prominent biopharmaceutical firm, has declared that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Dordaviprone (ONC201). The medic...

Dr. Zhang Wei: Leading Innovation in Epigenetic Therapy for Diffuse Midline Glioma at Tsinghua University

IntroductionDiffuse midline glioma (DMG) remains one of the most aggressive and devastating brain tumors in children and young adults. Surgical removal is often impossible due to its deep-seated midli...

ONC201 Capsules: A New Hope for Brain Glioma Patients in China

Gliomas IntroductionBrain gliomas, especially aggressive types such as glioblastoma multiforme (GBM), have long been extremely challenging to treat because of their insensitivity to traditional therap...

Pembrolizumab is approved by the USFDA for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

On March 19, 2025, the Food and Drug Administration officially approved pembrolizumab (Keytruda, Merck) to be used along with trastuzumab and chemotherapy that includes fluoropyrimidine and platinum f...

Brentuximab vedotin with lenalidomide and rituximab is approved by the USFDA for relapsed or refractory large B-cell lymphoma

On February 11, 2025, the Food and Drug Administration authorized the use of brentuximab vedotin (Adcetris, Seagen Inc., a subsidiary of Pfizer) in conjunction with lenalidomide and a rituximab produc...

Treosulfan with fludarabine is approved by the USFDA as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS

On January 21, 2025, the Food and Drug Administration sanctioned treosulfan (Grafapex, medac GmbH), an alkylating agent, in conjunction with fludarabine as a preparative regimen for allogeneic hematop...

Fam-trastuzumab deruxtecan-nxki is approved by the USFDA for unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer

On January 27, 2025, the Food and Drug Administration sanctioned fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for unresectable or metastatic hormone receptor (HR)-positive, HER2-low...

Datopotamab deruxtecan-dlnk is approved by the USFDA for unresectable or metastatic, HR-positive, HER2-negative breast cancer

On January 17, 2025, the Food and Drug Administration sanctioned datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-targeted antibody and topoisomerase inhibitor conjugate, for adu...

Sotorasib with panitumumab is approved by the USFDA for KRAS G12C-mutated colorectal cancer

On January 16, 2025, the Food and Drug Administration sanctioned the use of sotorasib (Lumakras, Amgen Inc.) in conjunction with panitumumab (Vectibix, Amgen Inc.) for adult patients diagnosed with KR...

Acalabrutinib with bendamustine and rituximab is approved by the USFDA for previously untreated mantle cell lymphoma

On January 16, 2025, the Food and Drug Administration granted conventional approval to acalabrutinib (Calquence, AstraZeneca) in combination with bendamustine and rituximab for adults with previously ...

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