Brian Park, PharmD

The FDA has approved an expanded indication for Gardasil 9® (human papillomavirus 9-valent vaccine [HPV], recombinant; Merck) to include the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58 in patients aged 9 to 45 years.

he designation is supported by data from a phase 1 trial conducted by Reata Pharmaceuticals in 2016. Findings from the study showed 44% of patients treated with berubicin (n=11 out of 25) experienced a statistically significant improvement in progression free survival.

The FDA has approved Opdivo® (nivolumab; Bristol Myers Squibb) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in some patients with nonmyeloid malignancies.

The FDA has approved Tecentriq® in combination with Avastin® for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

The FDA has approved Alunbrig® (brigatinib; Takeda) as a first-line treatment of adults with anaplastic lymphoma kinase(ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

The approval was based on data from the phase 3 IMpower110 study that compared the efficacy and safety of atezolizumab monotherapy to platinum-based chemotherapy in PD-L1-selected, chemotherapy-naive patients with stage IV NSCLC without ALK or EGFR mutations.

The FDA has approved Lynparza® (olaparib; AstraZeneca and Merck) for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.

The FDA has granted accelerated approval to Rubraca for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

The FDA has approved Qinlock™ (ripretinib; Deciphera) for the treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.