AstraZeneca’s cancer drug Tagrisso gets FDA approval
The FDA has approved AstraZeneca’s Tagrisso (osimertinib) for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent.
The approval was granted under the FDA’s Real-Time Oncology Review pilot programme, which aims to ensure that safe and effective treatments are available to patients as early as possible. Five national health authorities collaborated with the FDA on this review, including Health Canada, the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency (Anvisa), Swissmedic, and Singapore Health Sciences Authority. The UK’s MHRA participated in the review as an observer.
Approval of the drug was based on results from the ADAURA Phase III trial. Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC, as well as in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint.
Adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in the primary endpoint of disease-free survival in patients with Stage II and IIIA disease, while disease-free survival results in the overall trial population of patients with Stage IB-IIIA disease showed Tagrisso reduced the risk of disease recurrence or death by 80%.
At two years, 89% of patients treated with Tagrisso remained alive and disease free compared with 52% on placebo after surgery, the current standard of care. The safety and tolerability of Tagrisso in this trial was consistent with previous trials in the metastatic setting.
While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.
Dr Roy S. Herbst, Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, and principal investigator in the ADAURA Phase III trial, said: “Adjuvant Tagrisso has demonstrated an unprecedented disease-free survival benefit for early-stage lung cancer patients with EGFR mutations who face high rates of recurrence even after successful surgery and subsequent chemotherapy.
“This approval reinforces how critical it is to test all lung cancer patients for EGFR mutations before deciding how to treat them and regardless of their stage at diagnosis. This will help ensure as many patients as possible can benefit from this potentially practice-changing treatment.”
Nexcella has announced that the US Food and Drug Administration (FDA) has granted orphan drug …
AstraZeneca and Daiichi Sankyo have shared positive high-level results from the TROPION-Breast01 phase 3 trial, …