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FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag

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Teliso-V is currently in a 233-patient phase 2 study (LUMINOSITY) involving subjects with c-Met-positive, non-squamous NSCLC as a second- or third-line treatment after chemotherapy, immunotherapy with checkpoint inhibitors or drugs targeted at specific mutations. Preliminary results from that study showed a 53.8%

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Blue Note leukaemia DTx gets FDA breakthrough tag

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The DTx, called BNT200, is described as a first-of-its-kind DTx to treat anxiety and depression in adults with acute myeloid leukaemia (AML) who are hospitalised for a regimen of high-intensity induction chemotherapy. The DTx is an on-demand stress management intervention with content synchronised with high-intensity chemotherapy treatment.

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FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

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Patritumab deruxtecan achieved an overall response rate of 25% when given as a therapy to patients with EGFR-mutated NSCLC whose cancer had progressed despite treatment with a third-generation EGFR inhibitor like AstraZeneca’s Tagrisso (osimertinib) and platinum-based chemotherapy.

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Enhertu gets breakthrough tag in HER2-low breast cancer

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The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of chemotherapy.

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Gilead tags Merck for first-line triple negative breast cancer trial

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Trodelvy has already established itself as a go-to therapy for TNBC patients whose disease has progressed after prior treatments, says Gilead, while Keytruda is approved as a first-line therapy for the cancer in combination with chemotherapy, in patients with PD-L1 scores of 10 or more. While its headline revenue of $7.4

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Roche nabs breakthrough tag for TIGIT cancer immunotherapy

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Roche’s drug is already FDA-approved as a monotherapy and in combination with Avastin (bevacizumab) and chemotherapy for previously-untreated NSCLC with high PD-L1 expression. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

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STAT+: Bone marrow transplant advance could widen use of this less buzzy cure for sickle cell disease

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This approach has been around for decades but required patients to have a well-matched donor and endure a hefty dose of chemotherapy, ruling out transplant as an option for the vast majority of patients. These drugs have price tags of $2.2 million and $3.1 million, respectively.