FDA Update: February 2018

Feb 13, 2018
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

Express Scripts’ Emerging Therapeutics team monitors new drug approvals, new generics and other actions from the U.S. Food and Drug Administration (FDA). Here are some important approvals and updates we tracked over the past month:

Pediatric Use Extended for Fluarix

On Jan. 11, 2018, the FDA approved the use of Fluarix® Quadrivalent (influenza vaccine - GlaxoSmithKline) for children as young as six months old. It contains four strains of inactivated, standardized influenza virus that produce antibodies after vaccination. Dosing is the same (0.5mL) for all age groups. For children up to eight years old who have not had flu vaccinations before, two doses are recommended to be given one month or more apart in the first year. Most previously vaccinated children need only one shot per flu season, but particularly vulnerable children, such as those with serious chronic health conditions, may be better protected with two. Complete prescribing information is available here.

New Indication for Lynparza

Lynparza® (olaparib tablets – AstraZeneca) received approval from the FDA for a new indication on Jan. 12, 2018. Originally approved to treat a specific type of advanced ovarian cancer, it now is indicated for metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has mutations in the BRCA gene. A companion diagnostic blood test identifies patients appropriate for treatment. Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme used by cancer cells to restore their DNA. It is the first PARP inhibitor to gain an indication for breast cancer and the first drug of any class to be designated for BRCA-mutation breast cancer. Recommended dosing is 300mg (two 150mg tablets) twice a day for as long as the cancer is managed and the patient is not experiencing unbearable side effects. The capsule form of Lynparza is not interchangeable with the tablets. Prescribing information is available here.

Expanded Indication for Gilotrif

Boehringer Ingelheim’s tyrosine kinase inhibitor (TKI), Gilotrif® (afatinib) received additional approval from the FDA on Jan. 12, 2018. Its use was extended to the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) tumors that have non-resistant epidermal growth factor receptor (EGFR) L861Q, G719X and/or S768I mutations as verified by an FDA-approved diagnostic test. Gilotrif has previous approvals for treating squamous cell carcinoma of the lung that has progressed after treatment with platinum-based chemotherapy (chemo) and also for treating NSCLC with EGFR exon 19 deletions and/or exon 21 L858R mutations. Recommended dosing for most patients is one 40mg tablet each day until the cancer gets worse or the side effects become too severe. Taking Gilotrif may be associated with serious diarrhea, skin reactions and liver damage. It may harm a developing baby if taken during pregnancy. For prescribing information, click here.

Trisenox Receives New Indication

Under priority review, the FDA approved Trisenox® (arsenic trioxide – Teva) injection on Jan. 12, 2018, as initial treatment for certain patients who have acute promyelocytic leukemia (APL). It is now indicated to treat adults newly-diagnosed with low-risk APL characterized by t(15;17) translocations or PML/RAR-alpha gene expression. Its original FDA approval was for the same indication, but only after treatment with chemo. Used along with tretinoin, Trisenox is given by intravenous (IV) infusions at weight-based doses to induce remission and then for consolidation therapy. The total number of doses in each phase is limited. In addition, using Trisenox may cause serious side effects, such as heart blockages, other heart problems and a syndrome affecting lung function, that require boxed warnings on its label. Patients may need electrocardiograms and electrolyte tests before and during treatment. Full prescribing information for Trisenox is available here.

New Indication for Trulance

Trulance® (plecanatide – Synergy Pharmaceuticals), first approved by the FDA one year ago to treat chronic idiopathic constipation, now has an additional indication. It was approved on Jan. 25, 2018, for treating adults who have irritable bowel syndrome with constipation (IBS-C). According to the International Foundation for Functional Gastrointestinal Disorders, irritable bowel syndrome (IBS) affects between 10% and 15% of Americans, but many have not been diagnosed. Approximately two-thirds of patients with IBS are female, and patients usually are younger than 50 years of age when diagnosed. Although no specific cause is known, about 10% of IBS cases follow a stomach infection. Stress and food intolerances also have been linked to episodes. Symptoms, which vary widely in both severity and frequency, include abdominal discomfort, bloating, cramping, gas and mucus in the stool. Patients also have chronic constipation, diarrhea (IBS-D) or a mixture of both (IBS-M). In two clinical trials, patients with IBS-C who took Trulance averaged fewer symptoms and more normal bowel movements than patients who were taking an inactive placebo. Recommended dosing is one tablet (3mg) once daily. Trulance should not be used by patients younger than 18 years old because it could cause serious, even fatal, dehydration. Updated prescribing information is available here

New Radiopharmaceutical Approved

Under Priority Review, the FDA approved Lutathera® (lutetium Lu 177 dotatate – Advanced Acceleration Applications) on Jan. 26, 2018. The first radiopharmaceutical indicated to treat adults who have gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Lutathera already had Orphan Drug status. It contains a peptide that targets cancer cells and a radioactive element that destroys them. Radiopharmaceuticals give off low levels of radiation to diagnose or treat diseases. The peptide part of Lutathera sticks to somatostatin receptors on tumor cells and then invades the cells where the radiation damages the cancer’s DNA beyond repair. Recommended dosing is two vials given by IV infusion once every eight weeks for four cycles. Neuroendocrine tumors usually occur in hormone-releasing organs, such as the thyroid and pancreas, that are influenced by nerve impulses. GEP-NETs is relatively rare – thought to affect about 171,000 Americans with approximately seven new cases diagnosed annually for every 100,000 in population. Most patients are diagnosed after the age of 50, partly because GEP-NETs progress slowly with few symptoms. Advanced Acceleration Applications, a Novartis subsidiary, has not released launch plans or pricing. However, because radiopharmaceuticals need precise handling, Lutathera will be administered by physicians who are trained and authorized to give radioactive treatments and in facilities that are equipped to minimize exposure to radiation. Although it will be added to the specialty drug list, Lutathera will not be available through Accredo since it will be delivered directly to the sites where it is given. Complete prescribing information can be found here.

New Dosage Form for Vancomycin

Firvanq™ (vancomycin – CutisPharma, Inc.) for oral solution was FDA approved on Jan. 29, 2018. The first oral liquid form of vancomycin, it is indicated to treat Clostridium difficile diarrhea and Staphylococcus aureus enterocolitis (inflammation of the small intestine and colon). Available in other formulations since the 1960s, vancomycin generally is reserved for serious infections that have not responded to other antibiotics, including methicillin. Firvanq will be marketed in two strengths: 25mg/mL and 50mg/mL. Its launch is planned for April 2, 2018. Prescribing information is available here.

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