European regulatory advisors are supporting approval of AstraZeneca’s lung cancer drug Tagrisso in the first-line setting.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended expanding the drug’s label to include the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
“This positive recommendation acknowledges Tagrisso’s [osimertinib] potential as a new first-line standard of care for patients with EGFR-mutated NSCLC in Europe,” noted the firm’s chief medical officer Sean Bohen.
“It reflects the strength of the FLAURA data that show Tagrisso delivered a statistically-significant and clinically-meaningful improvement in progression-free survival over the EGFR-TKI comparator arm across all pre-specified patient subgroups, including those with or without central nervous system metastases.”
According to the data, which underpinned US approval in this setting just days ago, progression free survival in patients taking Tagrisso was 18.9 months compared to 10.2 months for those receiving the standard of care, while the objective response rate was 80 percent versus 76 percent, respectively.
A new analysis of FLAURA results presented at the European Lung Cancer Conference (ELCC) in Geneva also showed that the drug’s PFS benefit over EGFR tyrosine kinase inhibitors (TKIs) was sustained throughout post-progression outcomes.
Tagrisso was initially approved in several countries around the globe as a second-line treatment for patients with EGFR T790M mutation-positive advanced NSCLC.
Elsewhere, the CHMP also recommended extending indications for: UCB Pharma SA’s Cimzia (certolizumab pegol) to treat plaque psoriasis in adults who are candidates for systemic therapy; Amgen’s Prolia (denosumab) for bone loss associated with long-term systemic glucocorticoid therapy in adult at increased risk of fracture; Bristol-Myers Squibb’s Sprycel (dasatinib) for the treatment of paediatric patients with newly diagnosed Ph+ CML in chronic phase or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib; and Pfizer’s Xeljanz (tofacitinib) in combination with methotrexate for the treatment of active psoriatic arthritis in certain patients.