FDA Update: June 2017

Jun 15, 2017
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

During May, the U.S. Food and Drug Administration (FDA) approved several novel drugs, numerous new indications and a major generic. Key updates as monitored by Express Scripts’ Emerging Therapeutics team include:

Imfinzi Approved for Bladder Cancer

The FDA gave accelerated approval to AstraZeneca’s Imfinzi™ (durvalumab) on May 1, 2017. It is a programmed death ligand 1 (PD-L1) inhibitor approved for use in patients whose locally advanced or metastatic urothelial carcinoma (bladder, ureter and/or urethra cancer) progresses during or following platinum-containing chemotherapy. Imfinzi also is indicated for patients who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Urothelial carcinoma accounts for around 90% of bladder cancer cases, affecting nearly 80,000 Americans each year. Recommended dosing for Imfinzi is 10mg/Kg of body weight once every two weeks as a one-hour intravenous (IV) infusion. Complete prescribing information is available here.

Radicava Approved to Treat Amyotrophic Lateral Sclerosis

On May 5, 2017, the FDA approved Radicava™ (edaravone injection) for IV use. It treats patients with amyotrophic lateral sclerosis (ALS). Also known as Lou Gehrig’s disease, ALS gradually destroys the nerves involved in voluntary movement. Radicava’s manufacturer, MT Pharma America, a subsidiary of the Japanese company Mitsubishi Tanabe Pharma Corp., plans a U.S. launch in August. Each 60mg (two IV bag) Radicava dose will be given by a health provider as a 60-minute infusion. During the first 28-day dosing cycle, it will be administered once a day on the first 14 days, then not at all for the next 14 days. Subsequent cycles will include infusions of Radicava on 10 of the first 14 days, then 14 days without treatment. Complete prescribing information can be found here.

Second Indication for Bavencio

Under FDA’s accelerated approval program, Bavencio® (avelumab) was approved on May 9, 2017, to treat patients with locally advanced or metastatic urothelial carcinoma that has progressed during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Once urothelial carcinoma metastasizes, the five-year survival rate is only about 5%. Bavencio is a PD-L1-blocking antibody given by IV infusion once every two weeks. Jointly developed by EMD Serono and Pfizer, it originally was FDA approved on March 23, 2017, to treat Merkel cell carcinoma, an aggressive type of skin cancer. Complete prescribing information for Bavencio is available here.

FDA Expands Approved Use of Kalydeco

The FDA has expanded the approved use of Kalydeco® (ivacaftor – Vertex), a product for treating cystic fibrosis (CF) in patients at least 2 years of age. Previously, it was indicated for use in patients who had one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The new indication, granted on May 17, 2017, expanded its use to include patients who have one mutation in the CFTR gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. This expanded indication increases treatment to include 33 mutations, impacting approximately 900 additional patients in the United States. Full prescribing information can be found here.

New Indications for Keytruda

On May 18, 2017, Merck’s Keytruda® (pembrolizumab) received accelerated approval to treat locally advanced or metastatic urothelial carcinoma in patients who are not eligible for cisplatin-containing chemotherapy. It also was approved to treat patients with locally advanced or metastatic urothelial carcinoma who have progressed on or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Less than a week later, Keytruda became the first drug FDA approved to treat multiple types of cancer that have specific genetic characteristics (biomarkers), rather than cancers that develop from a particular tissue. This latest indication is for treating colorectal cancer and any solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). It can be used by both adults and children who have exhausted available treatments for appropriate inoperable or metastatic cancers that have worsened despite previous drug therapy. A PD-1-blocker, Keytruda boosts the immune system’s ability to attack cancer cells. Keytruda is administered by IV infusion once every three weeks for up to two years, until the cancer begins to progress or until the patient can no longer take the drug. The recommended dose of Keytruda for children is 2mg/Kg of body weight (up to 200mg); for adults, the dose is 200mg. Updated prescribing information is available here.

Kevzara Approved to Treat Rheumatoid Arthritis

Sanofi and Regeneron Pharmaceuticals received approval for Kevzara® (sarilumab) from the FDA on May 22, 2017. It is indicated to treat adults who have moderate-to-severe rheumatoid arthritis (RA) that has not been controlled adequately by previous treatment with other disease-modifying antirheumatic drugs (DMARDs). Kevzara is a monoclonal antibody that blocks interleukin-6 (IL-6), which is associated with inflammation. Recommended dosing is one 200mg subcutaneous (SC) injection once every two weeks either alone or in combination with methotrexate or other non-biological RA drugs. Labeling for Kevzara carries a boxed warning that patients using it are at an increased risk of developing infections, including some that may be life threatening. It was launched upon approval through open distribution. Full prescribing information is available here.

Actemra Approved to Treat Giant Cell Arteritis

An additional indication was granted by the FDA, for Genentech’s Actemra® (tocilizumab). An IL-6 inhibitor, first approved in 2010 to treat RA, it also has indications for types of juvenile arthritis. On May 22, 2017, it became the first drug approved for patients with giant cell arteritis. Sometimes called temporal arteritis because it mainly affects arteries in the head and neck, giant cell arteritis involves inflammation of the inside linings of the arteries. The disease usually occurs after the age of 50 years, and is about three times more common among women as men. In the United States, only around 700 individuals in every 100,000 of population have it. To treat giant cell arteritis, 162mg of Actemra will be injected SC once a week. Initially, it will be given along with a corticosteroid, but the steroid dose will be decreased gradually until it is stopped. The label for Actemra cautions that its use may predispose patients to having opportunistic bacterial, fungal, viral or other infections. Before Actemra is started, prospective patients should be tested for latent tuberculosis. Prescribing information can be found here.

Generic Strattera Launched

The FDA approved the first AB-rated generics to Lilly’s Strattera® (atomoxetine), a non-stimulant drug for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Several generic manufacturers received approval on May 30, 2017; and generic exclusivity was not granted. Therefore, shipments of the FDA-approved generics have already begun.

Rebinyn Approved for Hemophilia B

On May 31, 2017, the FDA approved Rebinyn® [Coagulation Factor IX (Recombinant), GlycoPEGylated] from Novo Nordisk. Also known as nonacog beta pegol or N9-GP, Rebinyn is an extended-release form of blood clotting Factor IX. It is indicated to control bleeding episodes, including before and after surgery, for patients with hemophilia B. Dosing is as needed and it is infused IV at 40 international units (IU) per Kg of the patient’s body weight for minor-to-moderate bleeds or minimally invasive procedures; and 80IU/Kg for more serious bleeds or major surgery. Rebinyn is not approved for regular use to prevent bleeding episodes. Complete prescribing information is available here.

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