Shots: The EC’s approval is based on P-III ALTA-1L study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib (250mg, bid) in 275 patients with ALK+ LA/m-NSCLC prior not treated with an ALK inhibitor The P-III ALTA-1L study results: Alunbrig showed superiority in anti-tumor activity, @2+yrs. follow up, reduction in risk of […]Read More
Shots: The approval is based on P-III IMpower150 study results assessing Tecentriq + CT (paclitaxel & carboplatin) + Avastin (bevacizumab) (w or w/o) in 1202 patients in ratio (1:1:1) with Stage IV or recurrent mNon-sq NSCLC not treated with CT P-III IMpower150 study results (Tecentriq + carboplatin and paclitaxel, Tecentriq +Avastin + carboplatin & paclitaxel, […]Read More
Shots: The approval is based on P-I/II (B7461001) study assessing Lorbrena (100mg, qd) in 215 patients with ALK-positive metastatic NSCLC, who were treated with one or more ALK TKIs The P-I/II (B7461001) study resulted in ORR (48%) with intracranial response rate 60% with serious AEs 32% out of 295 patients Lorbrena (lorlatinib) is a third-generation […]Read More
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