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approvalsWatch: Oncology 260216

US FDA Approvals

Palbociclib
Palbociclib, which targets CDK4 and CDK6, has been approved by the FDA in conjunction with fulvestrant for the treatment of HR-positive, HER2-negative breast cancer in women who have failed prior endocrine therapy for advanced or metastatic disease. 

Obinutuzumab
Following FDA approval, patients with follicular lymphoma who have relapsed after or are refractory to a rituximab-containing regimen can be treated with obinutuzumab together with bendamustine followed by obinutuzumab monotherapy. The anti-CD20 monoclonal antibody was granted priority review.

Everolimus
The mTOR inhibitor everolimus has been approved for the treatment of adult patients with progressive, well-differentiated, non-functional, neuroendocrine tumours of the gastrointestinal tract or lung with inoperable, locally advanced or metastatic disease. 

European Medicines Agency Approvals

Trifluridine/Tipiracil
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation to the combination trifluridine/tipiracil tablet for the treatment of adult patients with metastatic colorectal cancer. Patients should have previously received available therapies, such as fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapeutic regimens, and anti-VEGF and anti-EGFR agents. The combination drug is also indicated for patients not considered suitable candidates for these therapies. 

Nivolumab
CHMP has adopted a two new positive opinions expanding the indications for nivolumab. The anti-PD-1 agent is now indicated for the treatment of previously treated adults with unresectable renal cell carcinoma and for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after chemotherapy in addition to individuals with advanced unresectable or metastatic melanoma. 

Afatinib
Afatinib monotherapy is now indicated for the treatment of locally advanced or metastatic squamous NSCLC that has progressed on or after platinum-based chemotherapy following the adoption of a positive opinion by the CHMP regarding a change in the marketing authorisation. The EGFR/HER2 tyrosine kinase inhibitor (TKI) is also indicated for patients with locally advanced or metastatic NSCLC with activating EGFR mutations who have not previously received TKI therapy.