#FDA approval

Osimertinib led to improved progression-free survival in people with common EGFR mutations.

Dual checkpoint inhibitors improve response rate and survival for people with intermediate or poor risk.

Study showed patients receiving rucaparib had significant improvement in progression-free survival.

FDA will work in close partnership with patients to incorporate their experience into benefit-risk assessments.

Approval extended to people who are in remission but have minimal residual disease.

Approval was based on trials enrolling newly diagnosed patients and those with resistant disease.

Indication extended to include first-line treatment of HR-positive/HER2-negative advanced or metastatic disease.

Abemaciclib approved for first-line treatment of HR-positive, HER2-negative breast cancer that has spread.

Durvalumab is first drug approved to prevent progression of stable cancer after chemotherapy and radiation.

Erleada delayed cancer progression and death by two years in a Phase III trial.

Erleada prolonged the time to disease progression or death in the SPARTAN trial.

Approval was based on LATITUDE trial of patients with metastatic high-risk castration-sensitive prostate cancer.

Approval was based on a trial of 229 patients with locally advanced or metastatic somatostatin receptor-positive midgut carcinoid tumors.

FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations.

First FDA-approved treatment for patients with BRCA-mutated HER2-negative metastatic breast cancer.

Adding Perjeta to adjuvant therapy reduces risk of post-surgery breast cancer recurrence.