Remove tag nsclc
article thumbnail

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

pharmaphorum

Teliso-V (telisotuzumab vedotin) is pitching to become the first targeted cancer treatment for people with non-small cell lung cancer (NSCLC) whose tumours overexpress c-Met. The post FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag appeared first on. Preliminary results from that study showed a 53.8%

Antibody 111
article thumbnail

FDA gives Daiichi Sankyo’s HER3 drug a breakthrough tag

pharmaphorum

The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength of phase 1 results in patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer (NSCLC).

Drugs 72
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Rethinking Clinical Trials

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. Overall survival was significantly improved with a hazard ratio of 0.69, median OS of 14.5

article thumbnail

Roche nabs breakthrough tag for TIGIT cancer immunotherapy

pharmaphorum

The FDA’s breakthrough status is for tiragolumab plus Tecentriq is the first for a TIGIT drug, and covers the first-line treatment of patients with advanced-stage non-small cell lung cancer (NSCLC) that expresses high levels of PD-L1. The post Roche nabs breakthrough tag for TIGIT cancer immunotherapy appeared first on.

article thumbnail

Enhertu gets breakthrough tag in HER2-low breast cancer

pharmaphorum

.” AZ and Daiichi Sankyo have previously been awarded breakthrough designations for Enhertu as a treatment for second- and later-line therapy of HER2-positive breast cancer, as well as HER2-positive non-small cell lung cancer (NSCLC) and gastric cancer.

Sales 59
article thumbnail

CHMP backs J&J’s myeloma bispecific Tecvayli, ahead of US decision

pharmaphorum

That alliance also yielded $6 billion blockbuster Darzalex as well as Rybrevant (amivantamab), J&J’s first bispecific antibody which is used to treat EGFR-mutated non-small cell lung cancer (NSCLC). Tecvayli previously scored a priority medicines (PRiME) designation from the EMA and a breakthrough-therapy tag from the FDA.

article thumbnail

Clover biopharmaceuticals raises $230 M; BrainStorm after ALS; BARDA grants $5.65 M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset

Delveinsight

The company plans to use the capital to expand its pipeline of protein-based vaccines and biologic cancer therapies utilizing its innovative and proprietary Trimer-Tag technology platform. M LightDeck for SARS-CoV-2 antigen test; Libtayo for first-line advanced NSCLC subset appeared first on DelveInsight Business Research.