The FDA has approved a sublingual spray formulation of fentanyl (Subsys – Insys) for management of breakthrough pain in adult cancer patients who are receiving and are tolerant to opioid therapy (taking ≥60 mg/day of oral morphine or the equivalent). Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and transmucosal use.

The FDA has approved abiraterone acetate (Zytiga – Centocor Ortho Biotech) for oral treatment, in combination with prednisone, of metastatic castration-resistant prostate cancer in patients previously treated with docetaxel (Taxotere, and others). It is the first oral drug approved for this indication. Zytiga will compete with cabazitaxel (Jevtana) and sipuleucel-T (Provenge).

The FDA has approved the neoadjuvant (preoperative) use of pertuzumab (Perjeta – Genentech) in combination with trastuzumab (Herceptin) and docetaxel (Taxotere, and generics) for treatment of locally advanced, inflammatory, or early-stage HER2 (human epidermal growth factor receptor 2)-positive breast cancer patients with tumors >2 cm in diameter or node-positive disease. Pertuzumab in combination with trastuzumab and docetaxel was approved earlier for treatment of HER2-positive metastatic breast cancer. Pertuzumab is the first drug to be approved for neoadjuvant treatment of...

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis) has been approved by the FDA for use in combination with an aromatase inhibitor for first-line endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib is also available copackaged with the aromatase inhibitor letrozole (Femara, and generics) as Kisqali Femara Co-Pack. Ribociclib is the second CDK 4/6 inhibitor to be approved in the US for this indication;...

Ziv-aflibercept (Zaltrap – Sanofi/Regeneron), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA for use in combination with 5-fluorouracil, leucovorin and irinotecan (FOLFIRI) for treatment of metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen. It is the same drug as aflibercept, which was approved last year as an intravitreal injection (Eylea) for treatment of neovascular (wet) agerelated macular degeneration (AMD). Ziv-aflibercept is the second VEGF inhibitor approved for treatment...

Anastrozole (Arimidex - AstraZeneca, Medical Letter 1996; 38:61), an aromatase inhibitor, has received accelerated approval from the FDA for adjuvant treatment of postmenopausal women with early hormone-receptor-positive breast cancer. The drug was approved for treatment of postmenopausal women with metastatic breast cancer in 1996.

Erlotinib (Tarceva) is the second oral epidermal growth factor receptor (EGFR) inhibitor to become available in the US for treatment of advanced refractory NSCLC. In clinical trials, erlotinib produced a response rate of only 8.9%, but increased median survival from 4.7 to 6.7 months. Patients who had never smoked and those with EGFR-positive tumors survived longer. Erlotinib is generally well tolerated; diarrhea and rash are the most common adverse effects.

Regorafenib (Stivarga – Bayer), a multikinase inhibitor, has been approved by the FDA for treatment of patients with metastatic colorectal cancer previously treated with multiple other regimens specified in the labeling. It has also been approved for use in treatment-refractory, locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST).

The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. About 13-15% of lung cancers are small-cell cancers. Most SCLCs occur in patients who are current or former smokers.