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Besremi Approved for Rare Cancer
November 15, 2021 – PharmaEssentia’s Besremi® (ropeginterferon alfa-2b-njft) has been approved to treat polycythemia vera (PV) in adults. It is the only interferon drug FDA approved for this indication.
- PV is a rare blood cancer that occurs when the bone marrow makes too many red blood cells.
- Besremi is a subcutaneous injection that can be administered by a healthcare provider, caregiver, or the patient. Recommended initial dosing is 100mcg given by subcutaneous injection with a dosing schedule of once every two weeks. The dose is increased by 50mcg every two weeks, up to a maximum of 500mcg, until specific blood test values (hematocrit, platelets, and leukocytes) have stabilized (hematologic stability).
- If the patient maintains hematologic stability for at least one year on a stable dose of Besremi, dose frequency may be reduced to once every four weeks.
- If the patient is taking hydroxyurea, the initial dose of Besremi should be reduced to 50mcg, and the patient should discontinue hydroxyurea by Week 13 of taking Besremi.
- PharmaEssentia has launched Besremi at a wholesale acquisition cost (WAC) of $6,988 per syringe.
Ruxience Approved to Treat Rheumatoid Arthritis
November 15, 2021 – The U.S. FDA has approved a new indication for Ruxience® (rituximab-pvvr), Pfizer’s biosimilar for Genentech and Biogen’s Rituxan® (rituximab).
- Ruxience is now indicated for use in combination with methotrexate to treat adults who have moderately to severely active rheumatoid arthritis (RA) and have had an inadequate response to one or more tumor necrosis factor antagonists.
- This new indication matches the FDA-approved RA indication held by Ruxience’s reference product, Rituxan.
- Recommended dosing for Ruxience in the treatment of RA is two 1,000mg intravenous infusions separated by two weeks (one course) given every 16-24 weeks, based on clinical evaluation.
- The FDA first approved Ruxience in 2019. The drug is also indicated to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s granulomatosis), and microscopic polyangiitis.
Mvasi Receives New Cancer Indication
November 15, 2021 – Mvasi® (bevacizumab-awwb) has received a new indication to treat epithelial ovarian, fallopian tube, or primary peritoneal cancer. The drug, manufactured by Amgen, is a biosimilar for Genentech’s Avastin® (bevacizumab).
- Under the new indication, Mvasi is FDA approved for use in combination with:
- Carboplatin and paclitaxel, followed by Mvasi a single agent, for stage III or IV disease following initial surgical resection;
- Paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease in patients who have received no more than two prior chemotherapy regimens; or
- Carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Mvasi as a single agent, for platinum-sensitive recurrent disease.
- The new indication mirrors an FDA-approved indication for Mvasi’s reference product, Avastin.
- Recommend dosing and duration of treatment under the indication is based on individual patient factors such as treatment history, chemotherapy regimen, and disease state. Mvasi is administered by a healthcare provider via intravenous infusion over the course of 30-90 minutes, based on treatment tolerance.
- Mvasi first received U.S. FDA approval in 2017.
New Warning Added to Climara Pro Prescribing Information
November 18, 2021 – The U.S. FDA is expanding a black box warning, the most prominent warning that can be required on a drug label, for Bayer’s Climara Pro® (estradiol/levonorgestrel) transdermal patch. Climara Pro is used to treat the symptoms of menopause and prevent postmenopausal osteoporosis.
- The black box warning now cautions there is an increased risk of endometrial cancer in women with a uterus who use estrogen without the addition of progestin. Climara Pro contains both an estrogen (estradiol) and a progestin (levonorgestrel).
- Climara Pro also has black box warnings for cardiovascular disorders, dementia, and breast cancer.
- For treatment of menopause symptoms, Climara Pro should be used at the lowest effective dose and for the shortest duration possible. To prevent osteoporosis, Climara Pro has a recommended dose of one patch containing estradiol 0.045mg and levonorgestrel 0.015mg applied once weekly.
- The U.S. FDA first approved Climara Pro in 2003.