Your source for the latest industry trends and drug information news.
Volume 7 | Issue 3
February 1, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On January 17, 2025, the U.S. Food and Drug Administration (FDA) approved Datroway® (datopotamab deruxtecan) for the treatment of certain patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. HR+/HER2- is the most common subtype and accounts for approximately 70% of breast cancer cases. Datroway® is an antibody-drug conjugate (ADC) administered as an intravenous infusion every three weeks that selectively targets and kills tumor cells expressing the cell surface antigen Trop-2 while sparing healthy cells from damage, unlike traditional chemotherapy. Datroway® is the first ADC approved in the U.S.
Approval was based on the results of the TROPION-Breast01 clinical trial. The study enrolled 732 patients considered unsuitable for further endocrine therapy and who had received up to two lines of prior chemotherapy. Results showed that patients treated with Datroway® had a median progression-free survival (PFS) of 6.9 months compared to 4.9 months for those receiving chemotherapy with eribulin, capecitabine, vinorelbine or gemcitabine. Median overall survival was similar between the Datroway® and chemotherapy groups at 18.6 and 18.3 months, respectively. Side effects of the medication include mouth ulceration, nausea, vomiting, fatigue, hair loss, constipation, inflammation of the cornea, dry eye, increased liver enzymes and decreased white blood cell counts, calcium and hemoglobin.
On December 23, 2024, Astellas Pharma US, Inc. announced a voluntary recall of one lot of Prograf® 0.5mg (tacrolimus) capsules and one lot of Astagraf XL® 0.5mg (tacrolimus) extended-release capsules. These products are being recalled because the affected bottles may contain empty capsules. Prograf® and Astagraf XL® are immunosuppressive medicines used to prevent organ transplant rejection. Prograf® is used for people who have had kidney, heart, liver or lung transplants, and Astagraf XL® is for people with kidney transplants. Transplant patients who consume empty capsules would miss these doses of tacrolimus and may experience initiation of rejection of the transplanted tissue.
The impacted products were distributed nationwide to wholesale and retail outlets. The affected Prograf ® lot is 0E3353D with an expiration date of March 2026. The recalled Astagraf XL® lot is 0R3092A with an expiration date of March 2026. Astellas is notifying its customers via a drug recall notification letter and arranging for the return of the impacted product. To date, Astellas has not received any reports of adverse events related to this recall. Patients who have an affected lot should contact their physician or health care provider. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program.
On December 23, 2024, the FDA approved a generic version of the once-daily injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA) Victoza (liraglutide) to lower blood sugar in patients 10 years or older with type 2 diabetes (T2D). This authorization follows the approval of the first generic GLP-1 RA in November 2024, which referenced Byetta (exenatide), a twice-daily injectable product.
Type 2 diabetes is a chronic condition that occurs when the body does not use insulin well and cannot keep blood sugar at normal levels. Liraglutide improves blood sugar levels by creating similar effects in the body as GLP-1, which is often found in insufficient levels in patients with type 2 diabetes. Liraglutide comes with a warning of increased risk of thyroid C-cell tumors, so it should be avoided by patients who have a personal or family history of medullary thyroid carcinoma. It should also be avoided by patients with multiple endocrine neoplasia syndrome. Common side effects reported with liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, heartburn and constipation.
New Dosage Form: Brynovin™ (sitagliptin) oral solution
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [1/16/2025- AZURITY].
Mesnex® (mesna)
Indication: Prevention of hemorrhagic cystitis in cancer patients treated with ifosfamide chemotherapy. Treatment with ifosfamide can irritate the lining of the bladder, leading to inflammation and bleeding (hemorrhagic cystitis).
Dosage Form/Strength: 400mg tablet
Average Wholesale Price (AWP): Generic = $352| Brand = $377
