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The U.S. FDA has approved AVEO Pharmaceuticals’ Fotivda® (tivozanib) to treat relapsed or refractory advanced renal cell carcinoma (RCC) in adults who have had two or more prior systemic therapies. It is the first FDA-approved therapy for this indication.

Renal cell carcinoma is the most common form of kidney cancer and is most often diagnosed in individuals between 50 and 70 years old. The risk of RCC is increased by certain factors such as smoking, dialysis treatment, hepatitis C infection, cystic kidney disease, certain genetic conditions, and chronic abuse of certain prescription and/or over-the-counter medications. Patients whose disease is advanced following at least two prior lines of systemic therapy can be faced with limited treatment options and a poor prognosis.

In a clinical study, Fotivda delivered an objective response rate (ORR) of 18%, median progression free survival (PFS) of 5.6 months, and median overall survival (OS) of 16.4 months. It was compared to treatment with sorafenib, a current standard of care, which delivered an 8% ORR, median PFS of 3.9 months, and median OS of 19.2 months.

Recommended dosing with Fotivda is 1.34mg taken by mouth once daily with or without food for 21 days, followed by seven days off treatment, in a 28-day cycle that should be repeated until disease progression or unacceptable toxicity occur. Dose modification may be necessary if the patient has hepatic impairment and/or experiences adverse reactions.

AVEO plans to launch Fotivda March 31, 2021. Pricing is not yet available.

Merck, the manufacturer of Keytruda® (pembrolizumab), has voluntarily withdrawn the drug’s FDA-approved indication to provide third-line treatment of metastatic small cell lung cancer (SCLC) in patients whose disease has progressed on or after platinum-based chemotherapy and at least one other prior line of therapy.

The indication was granted accelerated FDA approval in June 2019. Continued approval was contingent upon completion of a post-marketing requirement to establish the superiority of treatment with Keytruda based on overall survival (OS) rates in a clinical study. Although Keytruda met a study endpoint for progression-free survival, it did not meet the OS endpoint.

This change affects only the indication for third-line treatment of metastatic SCLC. It does not affect the approval of Keytruda’s more than two dozen other indications for cancer treatment.

Keytruda’s SCLC withdrawal follows a similar move by Bristol Myers Squibb. The manufacturer had been granted accelerated FDA approval for Opdivo® (nivolumab) in 2018 to provide third-line treatment for SCLC that had progressed after platinum-based chemotherapy and at least one other line of therapy. Like Keytruda, Opdivo did not meet the OS endpoint in a confirmatory trial. Bristol Myers Squibb voluntarily withdrew Opdivo’s third-line SCLC indication at the end of 2020.

The U.S. FDA has approved Arazlo™ (tazarotene) lotion 0.045%, manufactured by Ortho Dermatologics. The product is indicated to provide topical treatment of acne vulgaris in patients who are at least nine years of age. Although the active ingredient has been FDA approved since 1997, Arazlo is the first tazarotene acne treatment available in a lotion form.

Acne is the most common skin condition seen in the United States, affecting up to 50 million people. It occurs when skin cells and oil become trapped in hair follicles. This can cause cysts, nodules, pimples, whiteheads, and blackheads. In some cases, the disease can be painful due to inflammatory lesions, and it can also cause scarring and significant emotional distress.

In a clinical study, Arazlo was found to have similar treatment success compared to Tazorac® (tazarotene – Allergan) Cream 0.1%, with fewer treatment-related adverse events. Only 2.9% of patients treated with Arazlo experienced an adverse event, compared to 5.6% with Tazorac. The lotion formulation may help patients tolerate Arazlo better than other tazarotene treatments due to the hydrating ingredients included in the formulation. Recommended dosing is a thin layer of Arazlo applied to affected areas once daily. Contact with the eyes, mouth, paranasal creases, and mucous membranes should be avoided.

Ortho Dermatologics plans to launch the product in the first half of 2020 but has not yet announced pricing plans.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

The U.S. FDA has issued a warning that serious breathing difficulties may occur in patients who have respiratory risk factors and use the medications gabapentin or pregabalin. Risk factors include advanced age, respiratory diseases such as chronic obstructive pulmonary disease (COPD) that reduce lung function, and concomitant use with central nervous system (CNS) depressants such as antidepressants, anxiolytics, and antihistamines.

Gabapentin and pregabalin, known collectively as gabapentinoids, are FDA-approved to treat a variety of conditions such as nerve pain, seizures, and restless leg syndrome. Gabapentin is available as a brand name medication (Neurontin®, Gralise®, Horizant®) and as a generic. Pregabalin is sold under the brand names Lyrica® and Lyrica® CR. Lyrica, but not Lyrica CR, became available as a generic in 2019.

To address the potential risks involved in the use of gabapentinoids, the FDA is requiring new warnings be added to the drugs’ prescribing information. The agency has also required manufacturers to conduct new clinical trials to further evaluate the drugs’ abuse potential. The misuse and abuse of gabapentinoids in combination with opioids has increased in recent years. The use of these classes of drugs together may raise the chances of serious respiratory difficulties.

Patients or their caregivers should seek immediate medical attention in the event of serious respiratory problems, as these can be life-threatening. Signs and symptoms include dizziness, shortness of breath, confusion, extreme lethargy, unresponsiveness, and bluish skin – especially on the lips, fingers, and toes. Healthcare professionals should prescribe gabapentinoids at the lowest possible dose. They should also carefully monitor elderly patients, patients who have underlying respiratory disease, and patients who also take a CNS depressant. Patients who meet these criteria should be advised of the risks and how to identify respiratory depression.

Further information regarding the warning can be found at the FDA’s website. Patients, caregivers, and healthcare providers are encouraged to report adverse events that may be related to the use of gabapentinoids to the FDA’s MedWatch program.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

The U.S. FDA has approved an expanded indication for Tiglutik® (riluzole) oral suspension, manufactured by ITF Pharma. Under the expansion, the product can now be administered via percutaneous endoscopic gastrostomy (PEG) tubes to treat amyotrophic lateral sclerosis (ALS).

ALS is a disease of the motor neurons that affects approximately 16,000 individuals in the United States. As motor neurons deteriorate and die off, the brain loses its ability to send signals to the body’s muscles. This causes progressive loss of voluntary movement, which often leads to difficulty swallowing and may necessitate the placement of a PEG tube to deliver nutrients, fluids, and medications directly to the stomach.

In a clinical study, Tiglutik oral suspension was found to be bioequivalent when administered via PEG tube compared to the previously approved oral route of administration. Recommended dosing is 50mg taken twice daily at least one hour before or two hours after a meal, with 12 hours between doses. The patient’s serum aminotransferases should be monitored before and during treatment.

Tiglutik’s active ingredient, riluzole, has been FDA approved to treat ALS since 1995.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.

The U.S. FDA has approved Amneal Pharmaceuticals’ generic version of Merck’s NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring). Amneal’s generic will be marketed under the name EluRyng™ and is the first generic alternative to NuvaRing to become available on the U.S. market.

EluRyng is lightweight, flexible vaginal ring that releases a combination of estrogen and progestin hormones indicated for use by women to prevent pregnancy. Under the recommended dosing, the ring should be inserted into the vagina for three weeks of continuous use. After the third week, EluRyng should be removed for a ring-free interval that last seven days. A new ring must then be inserted according to the recommended dosing to continue contraception.

Patients are able to insert and remove EluRyng on their own. However, they should speak to their doctor about proper use and the best time to insert the ring, as this can vary depending on the patient’s medical history and history of contraceptive use. A black box warning cautions that women over 35 years old who smoke should not use EluRyng, as smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use.

Amneal Pharmaceuticals has launched EluRyng at a wholesale acquisition cost of $148.32 per box, compared to $162.63 for NuvaRing.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.