Is Pirtobrutinib approved by the FDA?

Yes, Pirtobrutinib, marketed under the brand name Jaypirca, is FDA approved. The FDA granted accelerated approval to Pirtobrutinib on January 27, 2023. This approval is based on the response rate observed in clinical trials, and continued approval for these indications may depend on verification and description of clinical benefit in confirmatory trials.

Indications: 

Pirtobrutinib (Jaypirca) is approved for the treatment of adult patients with:

1. Relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
2. Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two lines of treatment, including a Bruton's tyrosine kinase (BTK) inhibitor and a BCL-2 inhibitor.

Mechanism of Action: 

Pirtobrutinib is an oral kinase inhibitor and specifically a non-covalent (reversible) BTK inhibitor. It works by blocking BTK, a signaling protein found across numerous B-cell leukemias and lymphomas, including MCL, CLL, and SLL. When BTK is blocked, it prevents the activation of pathways responsible for B-cell proliferation and growth, leading to the death of malignant B-cells.

Common Side Effects:

• Bruising
• Tiredness
• Diarrhea
• Swelling
• Muscle, joint, and bone pain
• Fever, chills
• Cough with mucus
• Chest pain
• Shortness of breath

Serious Side Effects:

• Allergic reactions (hives, difficulty breathing, swelling of the face, lips, tongue, or throat)
• Chest pressure, racing or pounding heartbeats, fluttering in the chest, shortness of breath
• Signs of infection (fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding)
• Bleeding inside the body (weakness, dizziness, pink or brown urine, abnormal vaginal bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds)
• Low blood cell counts (fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath)

Warnings and Precautions:

• Infections: Serious and fatal infections can occur. Consider prophylaxis, such as vaccinations and antibiotics, in those at increased risk.
• Bleeding: Serious and fatal bleeding events have occurred. Monitor for signs of bleeding and manage appropriately.
• Low Blood Cell Counts: Regular monitoring of blood counts is necessary.
• Cardiac Arrhythmias: Cardiac arrhythmias, including atrial fibrillation and atrial flutter, may occur.
• Second Primary Cancers: Skin cancers have occurred; use sun protection when outside.
• Fetal Harm: Pirtobrutinib can cause fetal harm. Use effective contraception during treatment and for 1 week after the last dose.

Storage: 

Store Pirtobrutinib tablets at room temperature between 68°F to 77°F (20°C to 25°C). The tablets come in a bottle with a child-resistant cap and should be kept out of reach of children and pets.

Conclusion: 

Pirtobrutinib, branded as Jaypirca, is an FDA-approved medication for treating certain types of relapsed or refractory lymphomas and leukemia. Its approval provides a new option for patients who have previously been treated with other BTK inhibitors. As with all medications, it is important to adhere to medical advice, be aware of potential side effects, and take necessary precautions to manage risks.

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