Updates from FDA
New drugs
TEPROTUMUMAB-TRBW
(Tepezza—Horizon Therapeutics Ireland)
Drug class: Insulin-like growth factor-1 receptor inhibitor
Indication: First drug approved for treatment of adults with thyroid eye disease, a rare condition in which the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outward (proptosis)
Recommended dosage: Administer by I.V. infusion over 60 to 90 minutes. Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg every 3 weeks for seven additional infusions.
Adverse effects: Muscle spasm, nausea, hair loss, diarrhea, fatigue, hyperglycemia, hearing loss, dry skin, altered sense of taste, headache
Warnings and precautions: Infusion reactions (interrupt or slow rate of infusion), exacerbation of preexisting inflammatory bowel disease (monitor patients and discontinue if IBD worsens), hyperglycemia (monitor glucose levels in all patients; treat hyperglycemia with glycemic control medications).
The drug should not be used if pregnant; verify pregnancy status before beginning treatment of women of child-bearing potential, and counsel on pregnancy prevention during treatment and for 6 months following the last dose.
TAZEMETOSTAT
(Tazverik—Epizyme)
Drug class: Methyltransferase inhibitor
Indication: Treatment of adults and children ages 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Tazemetostat blocks activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing. Most cases of epithelioid sarcoma begin in the soft tissue under the skin of an extremity, though it can start in other areas of the body. Surgical removal is considered the main treatment when the cancer is localized to one area of the body. Chemotherapy or radiation may also be given. However, there is a high likelihood for local and regional spread of the disease even with treatment, and approximately 50% of patients have metastatic disease at the time of diagnosis.
Recommended dosage: 800 mg taken orally twice daily with or without food
Adverse effects: Pain, fatigue, nausea, decreased appetite, vomiting, constipation
Warnings and precautions: Increased risk of secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia.
Females of reproductive potential should use effective contraception during treatment and for 6 months after the final dose. Males with a female partner of reproductive potential should use effective contraception during treatment and for 3 months after the final dose.
Females who are pregnant or breastfeeding should not take tazemetostat because it may cause harm to a developing fetus or newborn baby.
The drug must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.
New indication
OLAPARIB
(Lynparza—AstraZeneca)
Drug class: Poly (ADP-ribose) polymerase (PARP) inhibitor
Indication: Maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients are selected for therapy based on an FDA-approved companion diagnostic.
Recommended dosage: 300 mg taken orally with or without food. For moderate renal impairment (CrCL 31–50 mL/min), reduce dosage to 200 mg.
Adverse effects: Nausea or vomiting, tiredness or weakness, diarrhea, headache, changes in kidney function blood tests, low number of platelets, changes in the way food tastes, loss of appetite, low number of red or white blood cells, mouth sores, respiratory infections
Warnings and precautions: Risk of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), which may lead to death (monitor blood cell counts before treatment and every month during treatment, and stop treatment if MDS/AML is confirmed); pneumonitis, which can be fatal (interrupt treatment if suspect; discontinue if confirmed); embryo-fetal toxicity (advise of potential risk and to use effective contraception)
Through Rx-to-OTC switch, FDA approves three drugs for nonprescription use
All three drugs newly approved through FDA’s prescription (Rx)-to-OTC switch process will be marketed in the United States as nonprescription drugs and will no longer be available via prescription. They are as follows:
- Diclofenac sodium topical gel, 1% (Voltaren Arthritis Pain—GlaxoSmithKline), a NSAID for temporary relief of arthritis pain. It was first approved in 2007 as a prescription drug for treatment of the pain of osteoarthritis of joints responsive to topical treatment, in particular the joints of the hands, knees, and feet (it has not been shown to work for strains, sprains, bruises, or sports injuries).
- Olopatadine HCl ophthalmic solution/drops, 0.1% (Pataday Twice Daily Relief—Alcon) for temporary relief of itchy and red eyes resulting from pollen, ragweed, grass, animal hair, or dander. It was first approved in 1996 under the name Patanol as a prescription drug for treatment of allergic conjunctivitis.
- Olopatadine HCl ophthalmic solution/drops, 0.2% (Pataday Once Daily Relief—Alcon) for temporary relief of itchy eyes resulting from pollen, ragweed, grass, animal hair or dander. It was first approved in 2004 as a prescription drug for treatment of ocular itching associated with allergic conjunctivitis.
“As a result of the Rx-to-OTC switch process, many products sold over the counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” said Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in FDA’s Center for Drug Evaluation and Research, in an FDA press statement.
“Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription,” Mahoney continued. “This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another nonopioid treatment option.”
To initiate an Rx-to-OTC switch, the manufacturer of the prescription drug must provide data demonstrating that consumers can understand how to use the drug safely and effectively without the supervision of a health professional.
Patients who currently take prescription versions of these products and have questions about the Rx-to-OTC switch should talk to their pharmacist or primary care provider.
New oral immunotherapy mitigates allergic reaction to peanuts
FDA approved peanut allergen powder-dnfp (Palforzia—Aimmune Therapeutics) to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals ages 4 years and older. Those who take peanut allergen powder-dnfp must continue to avoid peanuts in their diets.
The immunotherapy cannot be used for emergency treatment of allergic reactions, including anaphylaxis, and should not be administered to patients with uncontrolled asthma.
Treatment consists of three phases: initial dose escalation, up-dosing, and maintenance. The powder, manufactured from peanuts, is packaged in pull-apart, color-coded 0.5-, 1-, 10-, 20-, and 100-mg capsules and in 300-mg sachets. The capsules are for initial dose escalation and up-dosing, and the sachets are for maintenance. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food—such as applesauce, yogurt, or pudding—that the patient then consumes.
The initial dose escalation phase is given on a single day. The up-dosing phase consists of 11 increasing dose levels and occurs over several months. Initial dose escalation, and the first dose of each up-dosing level, are administered under the supervision of a health professional in a health care setting with the ability to manage potentially severe allergic reactions, including anaphylaxis. Practitioners should counsel patients or their parents/caregivers to have injectable epinephrine available for immediate use at all times, to continue to avoid peanuts in their diet, and to know how to recognize the signs and symptoms of anaphylaxis.
The immunotherapy treatment comes with a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS) for anaphylaxis and will only be available through specially certified health care providers, health care settings, and pharmacies to patients who are enrolled in the REMS program. While anaphylaxis can occur at any time during treatment, patients are at highest risk during and after the initial dose escalation and the first dose of each up-dosing level.
In clinical trials, the most commonly reported adverse effects were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.