China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.
Genfleet Therapeutics (Shanghai) Co. Ltd. has obtained clearance from China’s National Medical Products Administration (NMPA) to advance GFH-375 (VS-7375) into a phase I/II study in patients with advanced solid tumors with KRAS G12D mutation.
A new approach against non-small-cell lung cancer (NSCLC) has combined immunotherapy with molecularly targeted therapy to activate the immune response and inhibit oncogenic pathways, which prevented tumor progression and eliminated cancer cells. Brigham and Women’s Hospital scientists have developed nanoparticles loaded with antibody conjugates that could deliver large amounts of treatment to the tumor tissue. This new strategy could improve the results of conventional immunotherapy in these patients and reduce toxicity of existing treatments.
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
As competition rises in the Keytruda (pembrolizumab) biosimilar space, Celltrion Inc. is the latest to announce that it filed an IND application to the U.S. FDA to start a global phase III trial for its own Keytruda biosimilar, dubbed CT-P51. Incheon, South Korea-based Celltrion, which previously said it would differentiate from the pack by developing an easier-to-administer subcutaneous biosimilar of pembrolizumab, announced June 17 plans to start a global comparative phase III study of CT-P51 and Keytruda.
Zymeworks Inc. has obtained IND clearance from the FDA for ZW-171, a novel T-cell targeting bispecific antibody for mesothelin (MSLN)-expressing cancers. Clinical development will begin this year, and additional applications will be filed in the second half of the year seeking trial clearances in other territories.
Trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugates became a topic of talk during the recent American Society of Clinical Oncology meeting in Chicago.
Pierre Fabre Laboratories (Pierre Fabre SA) has filed an IND application to the FDA to initiate a first-in-human trial with PFL-002 (VERT-002) for solid tumors, including non-small-cell lung cancer (NSCLC).
Miami-headquartered Summit Therapeutics Inc. expanded rights to Akeso Inc.’s non-small-cell lung cancer (NSCLC) drug, ivonescimab (SMT-112; AK-112), June 3 while raising $200 million to advance the therapy.
