FDA Drug Approvals to Know from March 2017

Learn about the new products and expanded indications approved by the FDA in March 2017.

1. Bavencio

The FDA granted accelerated approval to EMD Serono’s avelumab (Bavencio) on March 23, 2017.¹

Bavencio is indicated for the treatment of Merkel cell carcinoma, an aggressive form of skin cancer, in patients aged 12 years and older. The first medication to receive the FDA’s nod for this purpose, the drug is designed to target the PD-1/PD-L1 pathway, helping the body’s immune system to attack cancer cells.

Adverse events reported by trial participants treated with Bavencio include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reactions, rash, decreased appetite, and peripheral edema.

2. Dupixent

The FDA approved Sanofi and Regeneron’s dupilumab injection (Dupixent) on March 28, 2017.²

Dupixent is indicated for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD) whose disease is unable to be controlled by topical prescription therapies or for whom such treatments are not advisable. The drug, the first biologic medicine to receive approval for the treatment of AD, is a human monoclonal antibody that inhibits overactive signaling of IL-4 and IL-13 proteins.

Adverse events associated with the use of Dupixent include injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips. The drug can be used with or without topical corticosteroids, but should not be used in patients who are allergic to any of the drug’s ingredients.

3. Keytruda

The FDA expanded the indication of Merck’s pembrolizumab (Keytruda) on March 14, 2017.³

Previously approved for the treatment of advanced non-small cell lung cancer, advanced melanoma, and head and neck squamous cell cancer, Keytruda can now be used to treat patients with refractory or relapsed classical Hodgkin lymphoma. The drug is to be administered intravenously every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

The most common adverse events associated with the use of Keytruda include fatigue, pruritus, diarrhea, decreased appetite, rash, pyrexia, cough, dyspnea, musculoskeletal pain, constipation, and nausea.

4. Kisqali

The FDA approved Novartis’ ribociclib (Kisqali) on March 13, 2017.⁴

Kisqali is indicated for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic

breast cancer. The drug is to be taken, in combination with 4 weeks of any aromatase inhibitor, as a once-daily dose of 600 mg for a 3-week period, followed by 1 week without treatment.

The most common adverse events reported by trial participants treated with Kisqali include nausea, tiredness, diarrhea, hair loss, vomiting, constipation, headache, and back pain. Serious side effects linked to the drug’s use include heart rhythm problem, liver problems, and low white blood cell counts.

5. Noctiva

The FDA approved Serenity Pharmaceuticals’ desmopressin acetate nasal spray (Noctiva) on March 3, 2017.⁵

The nasal spray is indicated for the treatment of adults who awaken at least 2 times per night to urinate due to nocturia. The drug, taken approximately 30 minutes before going to bed, increases the absorption of water through the kidneys to reduce urine production.

Adverse events linked to the use of Noctiva include nasal discomfort, cold symptoms, nasal congestion, sneezing, high or increased blood pressure, back pain, nosebleeds, bronchitis, and dizziness. The FDA also noted that Noctiva should not be used by patients with symptomatic congestive heart failure, uncontrolled hypertension, and certain nasal conditions, and approved the drug with a boxed warning alerting providers to an associated risk of low sodium levels in the blood.

6. Xadago

The FDA approved Newron Pharmaceutical’s safinamide (Xadago) on March 21, 2017.⁶

The drug is indicated as an add-on treatment for patients with Parkinson’s disease who are already taking levodopa and carbidopa and who are experiencing “off” episodes in which the medication combination is not working effectively.

The most common adverse effects reported by trial participants treated with Xadago include uncontrolled involuntary movements, falls, nausea, and trouble sleeping or falling asleep.

7. Zejula

The FDA approved Tesaro’s niraparib (Zejula) on March 27, 2017.⁷

Zejula is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors have completely or partially shrunk in response to platinum-based chemotherapy.

Side effects linked to the drug’s use include anemia, thrombocytopenia, neutropenia or leukopenia, heart palpitations, nausea, constipation, vomiting, distention, diarrhea, mucositis, indigestion, dry mouth, fatigue, decreased appetite, urinary tract infection, AST/ALT elevation, myalgia, back pain, arthralgia, headache, dizziness, dysgeusia, insomnia, anxiety, nasopharyngitis, dyspnea, cough, rash, and hypertension.

References

• FDA approves first treatment for rare form of skin cancer [news release]. FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548278.htm. Accessed March 23, 2017.
• Sanofi and Regeneron announce FDA approval of Dupixent (dupilumab), the first targeted biologic therapy for adults with moderate-to-severe atopic dermatitis [news release]. Sanofi website. http://www.news.sanofi.us/2017-03-28-Sanofi-and-Regeneron-Announce-FDA-Approval-of-Dupixent-R-dupilumab-the-First-Targeted-Biologic-Therapy-for-Adults-with-Moderate-to-Severe-Atopic-Dermatitis. Accessed March 28, 2017.
• FDA Approves Merck’s Keytruda (pembrolizumab) for adult and pediatric patients with classical hodgkin lymphoma (cHL) refractory to treatment, or who have relapsed after 3 or more prior lines of therapy [news release]. Merck website. http://www.mrknewsroom.com/news-release/corporate-news/fda-approves-mercks-keytruda-pembrolizumab-adult-and-pediatric-patients-. Accessed March 15, 2017.
• Novartis Kisqali (ribociclib, LEE011) receives FDA approval as first-line treatment for HR+/HER2- metastatic breast cancer in combination with any aromatase inhibitor [news release]. Novartis website. https://www.novartis.com/news/media-releases/novartis-kisqalir-ribociclib-lee011-receives-fda-approval-first-line-treatment. Accessed March 14, 2017.
• FDA approves first treatment for frequent urination at night due to overproduction of urine [news release]. FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544877.htm. Accessed March 3, 2017.
• FDA approves drug to treat Parkinson’s disease [news release]. FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm547852.htm. Accessed March 21, 2017.
• FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers. FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548948.htm. Published March 27, 2017.