Expanded indication for Ibrance
In a financial report released on Jan. 31, 2023, Pfizer disclosed that the indication for Ibrance® (palbociclib) has been extended. Pfizer’s cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor is marketed in both oral capsules and tablets. On Dec. 13, 2022, the U.S. Food and Drug Administration (FDA) approved both for first-line use along with an aromatase inhibitor (anastrozole, exemestane, or letrozole) for treating metastatic, hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer for women of all ages. Previously, use of the regimen had been limited to men and postmenopausal women. Ibrance has an additional indication in combination with the injectable selective estrogen degrader (SERD), fulvestrant, for patients whose cancers have worsened after endocrine treatment. For all of its indications, Ibrance is taken on a 28-day cycle with 125mg once each day on the first 21 days, followed by seven days with no Ibrance. To boost absorption, capsules should be taken with food; tablets can be taken with food or without. Two other CDK4/6 inhibitors, Kisqali® (ribociclib – Novartis) tablets, and Verzenio® (abemaciclib – Eli Lilly and Company) tablets, also are FDA approved for treating HR+/HER2- breast cancers. Revised prescribing information for Ibrance capsules is here; for Ibrance tablets, here.
New Indication for Trodelvy
On February 3, 2023, the FDA also approved Gilead Sciences’ Trodelvy® (sacituzumab govitecan-hziy) injection as a treatment for HR+, HER2- metastatic breast cancer in patients who had already received endocrine-based therapy and at least two other systemic therapies. Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate initially approved in April 2020 for the treatment of metastatic triple-negative breast cancer (TNBC). HR+/HER2- metastatic breast cancer is the most common type of breast cancer, accounting for around 70% of all new cases. In the phase III trial of Trodelvy, overall survival (OS) was 3.2 months longer when compared to monotherapy with single-agent chemotherapy. Trodelvy is also approved to treat certain patients with metastatic urothelial cancer. Due to the possibility of serious side effects that can include neutropenia (very low numbers of specific white blood cells) and severe diarrhea that could cause lead to dehydration, Trodelvy has boxed warnings and a Medication Guide. Patients using it should be observed for signs of adverse effects during each infusion and for at least one-half hour after every treatment. Look here for prescribing information. At this time, the revised prescribing information has not yet been posted.
Tezspire Self-Administered Pen Approved On Feb. 2, 2023, the FDA approved Tezspire® (tezepelumab-ekko – AstraZeneca/Amgen) subcutaneous injection for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is a fully human monoclonal antibody known as a thymic stromal lymphopoietin (TSLP) blocker. Severe asthma affects 1.3 million people in the U.S. Despite using corticosteroids and albuterol inhalers, many patients’ asthma remains uncontrolled. Asthma is considered severe if the treatment requires medium-to-high doses of inhaled corticosteroids in combination with different long-acting treatments or if asthma remains uncontrolled even with correct use and adherence to medication. Severe uncontrolled asthma leads to frequent exacerbations, decreased lung function, impact on quality of life, and increased risk for hospitalization. Tezspire was first approved as an add-on therapy for no specific subtype of asthma. Approval was based on a clinical trial in which 92% of providers, patients, and caregivers were able to successfully administer Tezspire in both the clinic and at home, consistent with previous trials. The single-dose prefilled pen is available as 210 mg per 1.91 mL (110 mg/mL) solution and the recommended dose is 210mg subcutaneously every 4 weeks. For revised prescribing information, see here.