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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 3 | Issue 12
June 15, 2021

Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves First Targeted Therapy for Specific Non-Small Cell Lung Cancer Mutation

On May 28, 2021, the U.S. Food and Drug Administration (FDA) approved Lumakras™ (sotorasib) as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have a specific type of genetic mutation, called KRAS G12C, and who have received at least one prior systemic therapy. KRAS is a protein in the body that is involved in cell signaling pathways that control cell growth, cell maturation and cell death. Mutations in this protein cause unregulated cell growth, which can lead to the formation of cancerous tumors. About 25% of mutations in NSCLC are associated with the KRAS protein and the most common is KRAS G12C which accounts for about 13% of all NSCLC mutations. Cancers with KRAS mutations are notoriously difficult to treat as they are often resistant to conventional cancer drug therapies. Patients who fail first-line treatment typically have limited treatment options and face poor outcomes. Lumakras™, a once daily oral treatment, represents the first approved targeted therapy for KRAS mutations and works by locking the mutated KRAS protein in its inactive state, preventing downstream signaling that leads to unregulated cell growth. The accelerated approval was granted after results from a Phase II study, which included 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC who had experienced disease progression after receiving a prior therapy. The study showed that Lumakras™ shrank tumors and/or suppressed tumor growth in 81% of patients. In addition, 36% of patients who received Lumakras™ achieved destruction or reduction in size of tumors by at least 30%. Of those patients, 58% achieved a duration of response of six months or longer. The most common side effects of Lumakras™ included diarrhea, musculoskeletal pain, nausea, fatigue, liver damage and cough. These promising outcomes resulted in the Accelerated Approval, and the FDA will continue to review clinical data to verify the benefit Lumakras™ will have in this patient population

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Drug Safety

FDA Restricts Use of Ocaliva® Based on New Safety Data

On May 26, 2021, the FDA released a drug safety communication restricting the use of Ocaliva® (obeticholic acid) in patients diagnosed with primary biliary cholangitis (PBC) with advanced cirrhosis of the liver. PBC is a chronic liver disease that results from progressive destruction of the liver’s bile ducts, which play an important role in the body’s digestive system. As the disease progresses, scar tissue replaces healthy liver tissue causing liver function to decline, eventually leading to permanent liver damage, also known as cirrhosis. Ocaliva® is a prescription medication used to treat PBC in those patients who have not responded well enough to or cannot tolerate conventional treatment with Ursodiol® (ursodeoxycholic acid). The FDA has issued a new contraindication stating that Ocaliva® should not be used in PBC patients with advanced cirrhosis as a result of 25 identified cases of serious liver injury associated with its use in this patient population. The FDA also revised the Boxed Warning for Ocaliva®, stating that post marketing reports have shown potentially fatal liver deterioration and failure in patients with PBC with advanced cirrhosis or other liver impairment. The FDA is recommending that patients with PBC who have cirrhosis and are starting or currently taking Ocaliva® should talk to their health care provider about the new warning. Patients using Ocaliva® who develop any symptoms of worsening liver injury or development of cirrhosis should contact their health care provider immediately. Signs of liver-related adverse reactions can include nausea, vomiting, diarrhea, jaundice, yellowing of the eyes, and/or dark urine. Adverse reactions or side effects related to the use of Ocaliva® should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Moderna and Pfizer/BioNTech Apply for Full FDA Approval for COVID-19 Vaccines

On June 1, 2021, Moderna applied for full FDA approval of its COVID-19 vaccine for use in people 18 years and older. Earlier in May 2021, Pfizer and its partner, BioNTech, became the first coronavirus vaccine manufacturer to apply for full FDA approval of their COVID-19 vaccine for those 16 years and older. Both vaccines are currently available on the market under emergency use authorization (EUA), granted due to the ongoing COVID-19 pandemic which was declared a public health emergency by the United States. The EUA for a COVID-19 vaccine required that at least half of the trial participants had a minimum of two months of safety data before the FDA allowed it to enter the market. Now looking for full FDA approval, the makers of both vaccines have submitted the required Biologics License Application (BLA). As part of the application, the companies are asked to submit production/manufacturing information and all clinical data associated with the vaccine. Both Moderna and Pfizer/BioNTech have asked the FDA for priority review, which asks the FDA to make a ruling within six months, compared to the normal 10 months under a standard review. As part of this process, both companies will have to submit data to the FDA on a rolling basis over the coming weeks to support their applications. The approval process is expected to take months as FDA scientists will perform a thorough investigation of all clinical trial data to address any potential safety and efficacy concerns with the vaccines. Full approval of a COVID-19 vaccine would be an important milestone in the ongoing COVID-19 pandemic.

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FDA Approvals

New FDA Drug Approvals

Novel Drug Approval: Lybalvi™ (olanzapine and samidorphan)
Oral tablet approved for the treatment of adult patients with schizophrenia and bipolar I disorder [5/28/21 – ALKERMES INC]

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New Generics

New Generic Medications Entering the Marketplace

PreviDent® Alcohol Free (sodium fluoride mouthwash)
Indication: Prevention of dental cavities
Dosage Form/Strength: 0.2% (w/v) Oral solution
Average Wholesale Price (AWP): Generic =$16.48 | Brand = $18.31

Humatin™ (paromomycin sulfate)
Indication: Parasitic infection of the intestines, and add-on therapy to treat a coma induced by liver disease.
Dosage Form/Strength: 250 MG Oral capsule
Average Wholesale Price (AWP): Generic = $567 | Brand = $11,740
*Dosage regimen is based on weight and varies in days’ supply, therefore prices are per package (100 Capsules)