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Bristol Myers Squibb’s (BMS) Opdualag™ (nivolumab and relatlimab-rmbw) has received FDA approval to treat unresectable or metastatic melanoma in patients who are at least 12 years old.

• Opdualag combines nivolumab, the active pharmaceutical ingredient (API) in BMS’s Opdivo®, with a first-in-class LAG-3-blocking antibody, Both APIs help to increase the body’s immune activity to fight cancer cells.
• In adults and pediatric patients who are at least 12 years old and weigh at least 40kg (88 pounds), the recommended dosing is 480mg nivolumab and 160mg relatlimab administered by intravenous infusion once every four weeks until disease progression or unacceptable toxicity occur. The recommended dosing has not been established for pediatric patients at least 12 years of age who weigh less than 40kg.
• Although launch plans are not yet available, Opdualag is anticipated to have a wholesale acquisition cost (WAC) of $27,389 per infusion.

March 16, 2022 – Rinvoq® (upadacitinib), made by AbbVie, has a new indication to treatment moderately to severely active ulcerative colitis in adults who have had an inadequate response or intolerance to at least one tumor necrosis factor blocker.

• Recommended dosing under the new indication is 45mg once daily for eight weeks, followed by maintenance dosing of 15mg once daily. For patients who have refractory, severe, or extensive disease, a dose of 30mg once daily can be considered. Rinvoq should be used at the lowest effective dose to maintain response and should be discontinued if an adequate therapeutic response is not achieved at the 30mg dosage.
• First FDA approved in 2019, Rinvoq is also indicated to treat rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

The U.S. FDA has approved Mylan’s Breyna®, a generic for AstraZeneca’s Symbicort® (budesonide/formoterol fumarate dihydrate) inhalation aerosol. Brand name Symbicort first received FDA approval in 2006, and an authorized generic from Prasco launched in 2020.

• The first AB-rated generic for Symbicort, Breyna is indicated to provide:
  • Asthma treatment for patients at least six years of
  • Maintenance treatment for airflow obstruction and to reduce exacerbations for patients who have chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
• Recommended dosing is as follows:
  • Asthma (patients at least 12 years old): Two inhalations twice daily of either 80mcg budesonide/4.5mcg formoterol or 160mcg budesonide/4.5mcg formoterol. The starting dosage strength is based on asthma severity.
  • Asthma (patients six to less than 12 years old): Two 80mcg/4.5mcg inhalations twice
  • COPD: Two 160mcg/4.5mcg inhalations twice
• Mylan hopes to launch Breyna in 2022, depending on the outcome of patent litigation. Pricing information is not yet available.

Adlarity® (donepezil transdermal system) is FDA approved to treat mild, moderate, and severe Alzheimer-type dementia. It is the first once-weekly donepezil patch approved for this use in the United States.

• Made by Corium, Adlarity comes in 5mg/day and 10mg/day
• Recommended initial dosing is one 5mg/day patch applied per week. If needed, the dose can be increased after 4-6 weeks to one 10mg/day patch each week.
• Adlarity is expected to launch in the fall of Pricing is not yet available.

Lynparza® (olaparib – AstraZeneca and Merck) is now FDA approved as an adjuvant treatment for patients diagnosed with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative high-risk early breast cancer who have already received chemotherapy either before or after surgery.

• Lynparza is the first drug in its class (PARP inhibitors) to receive FDA approval for treatment of early breast cancer.
• The FDA first approved Lynparza in 2014 to treat ovarian The drug has since gained indications to treat pancreatic cancer, prostate cancer, and metastatic breast cancer.
• Recommended dosing for early breast cancer is 300mg taken twice daily for a total of one year, or until disease recurrence or unacceptable toxicity occur.

In accordance with a settlement agreement, Teva Pharmaceuticals has launched its generic for Bristol Myers Squibb’s Revlimid® (lenalidomide) in the United States. The FDA approved the generic on May 21, 2021.

• Like brand name Revlimid, Teva’s generic is indicated to treat:
  • Multiple myeloma when used in combination with
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality, with or without additional cytogenetic abnormalities.
  • Mantle cell lymphoma that has relapsed or progressed following two prior therapies, one of which included bortezomib.
• Unlike Revlimid, the generic is not currently FDA approved for:
  • Use as a multiple myeloma maintenance therapy in patients who have undergone autologous hematopoietic stem cell transplantation.
  • Use in combination with a rituximab product to treat follicular lymphoma or marginal zone lymphoma in patients who have received prior treatment.
• Teva’s generic is available in 5mg, 10mg, 15mg, and 25mg capsules. Revlimid is available in two additional dosage strengths (2.5mg and 20mg capsules) for which no generic is currently available on the S. market. Recommended dosing for both the brand name and generic product is based on the indication.
• Revlimid has a wholesale acquisition cost (WAC) of $17,497.73 per four-week supply compared to $15,118.04 for Teva’s generic.

Bristol-Myers Squibb’s Opdivo® (nivolumab) has received a new indication for use with platinum-doublet chemotherapy to treat adult patients who have resectable (tumors ≥ 4cm or node positive) non-small cell lung cancer in the neoadjuvant setting.

• Recommended dosing under the new indication is 360mg of Opdivo given as an intravenous infusion with platinum-doublet chemotherapy on the same day once every three weeks for three treatment cycles.
• First FDA approved in 2014, Opdivo holds indications to treat over half a dozen forms of cancer, including multiple indications for treating non-small cell lung cancer.

The U.S. FDA has approved Aspruzyo Sprinkle™ (ranolazine – Sun Pharmaceuticals) to treat chronic angina (chest pain). The drug may be used in conjunction with beta-blockers, nitrates, calcium channel blockers, antiplatelet therapy, lipid-lowering therapy, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers.

• Recommended dosing is 500mg taken twice daily. Dosing can be increased to a maximum of 1,000mg twice daily if needed based on clinical symptoms.
• Aspruzyo Sprinkle is supplied in unit-dose sachets of 500mg or 1,000mg. Each sachet contains granules that are added on top of a tablespoon of soft food (such as applesauce or yogurt) for oral administration or given with water via nasogastric tube or gastric tube.
• Launch and pricing information are not available.

Janssen Pharmaceuticals’ Carvykti™ (ciltacabtagene autoleucel; cilta-cel) is FDA approved to treat relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

• Carvykti is a chimeric antigen receptor T-cell (CAR-T) therapy created using the patient’s own immune cells. T-cells are collected from the patient and modified in a lab to specifically target multiple myeloma cells, then infused back into the patient.
• A one-time intravenous treatment, Carvykti must be given at a certified healthcare
• The product has launched at a wholesale acquisition cost (WAC) of $465,000.

Releuko™ (filgrastim-ayow – Kashiv Biosciences) for subcutaneous or intravenous use is now FDA approved as a biosimilar for Neupogen® (filgrastim – Amgen).

• Releuko is indicated to:
  • Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients who have nonmyeloid malignancies and are receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
  • Reduce the time to neutrophil recovery and the duration of fever following induction or consolidation chemotherapy treatment of patients who have acute myeloid leukemia.
  • Reduce the duration of neutropenia and neutropenia-related clinical sequelae (e.g.‚ febrile neutropenia) in patients who have nonmyeloid malignancies and are undergoing myeloablative chemotherapy followed by bone marrow transplantation.
  • Reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients who have congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
• Unlike Neupogen, Relueko has not received FDA approval to:
  • Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
  • Increase survival in patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).
• Recommended dosing for Releuko is based on the patient’s weight and the indication. If administration via subcutaneous injection rather than intravenous infusion is appropriate, Releuko can be given at home by a patient or caregiver trained in proper procedure.
• Although considered a therapeutic alternative for Neupogen, Releuko has not received FDA approval to be automatically interchanged for Neupogen at the pharmacy. Its wholesale acquisition cost (WAC) is $2,280 per syringe or vial.