Monthly News Roundup - December 2018
Elzonris is First Treatment for Rare, Aggressive Form of Blood Cancer
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) previously had no approved medical treatments. BPDCN, a hematologic cancer, may involve the bone marrow, skin, lymph nodes and viscera.
- In December, the FDA granted approval of Elzonris (tagraxofusp-erzs) from Stemline Therapeutics. Elzonris is a CD123-directed cytotoxin used intravenously (IV) in patients 2 years and older, and is the first approved CD123-targeted therapy.
- CD123 is a cell surface receptor expressed on a range of malignancies.
- In an open-label, single-arm study of 13 treatment-naïve patients, efficacy (the rate of complete response or clinical complete response [CR/CRc ]) was 53.8% (7/13).
- Commonly reported side effects include capillary leak syndrome, nausea, fatigue, and peripheral edema, among others.
ProAir Digihaler Cleared as First Digital Inhaler with Built-In Sensors
Teva’s ProAir Digihaler (albuterol sulfate 117 mcg) dry powder inhalation has been FDA-approved as the first digital inhaler with built-in sensors that connects to a mobile application using Bluetooth wireless technology. Patients can review and share their data with their doctor over time.
- ProAir Digihaler provides information about how often the inhaler is used and the inspiratory flow for patients with asthma and chronic obstructive pulmonary disease (COPD).
- ProAir Digihaler is used to prevent or treat bronchospasm as well as for prevention of exercise-induced bronchospasm in patients four years and older.
- Connection to the application is not needed for use of the inhaler medicine.
FDA Approves Motegrity for Chronic Idiopathic Constipation (CIC)
Shire’s Motegrity has been cleared by FDA as a once-daily, oral treatment for adults with chronic idiopathic constipation (CIC). CIC affects roughly 14% of the adult population, with symptoms of straining, bloating, hard stools, and fewer bowel movements.
- Motegrity (prucalopride) is a selective serotonin-4 (5-HT4) receptor agonist.
- In placebo-controlled studies, patients had an average of 3 or more weekly complete spontaneous bowel movements over 12 weeks, considered normalization of bowel movement frequency. Motegrity worked as early as the first week.
- The most common side effects with Motegrity were headache, stomach pain, nausea, and diarrhea, among others.
Herzuma is Cleared as a Biosimilar to Herceptin for Breast Cancer
Celltrion and Teva announce the approval of Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab) for HER2-overexpressing breast cancer (for adjuvant treatment or for metastatic disease).
- The FDA review showed no clinically meaningful differences between Herzuma and Herceptin for the approved indications.
- Herceptin is also approved for the treatment of HER2-overexpressing metastatic gastric cancer; however, Herzuma did not gain this use.
- Common side effects include: headache, chills, nausea, diarrhea, and fever, among others, depending upon use.
- Ogivri (trastuzumab-dkst) from Mylan is another approved biosimilar to Herceptin.
- Do not substitute Herzuma (trastuzumab-pkrb) for Kadcyla (ado-trastuzumab emtansine). Kadcyla also contains the chemotherapy drug emtansine.
FDA Approves Asparlas for Acute Lymphoblastic Leukemia (ALL)
Asparlas (calaspargase pegol-mknl) is an asparagine specific enzyme used as a component of cancer treatment for acute lymphoblastic leukemia (ALL). Depletion of plasma asparagine helps to kill the cancer cells.
- Asparlas is used in pediatric and young adult patients age 1 month to 21 years. This new product allows a longer dose interval compared to other available products.
- Asparlas, from Servier Pharmaceuticals, received FDA orphan product designation to treat a rare medical condition.
- Approval was based on achieving a nadir (low point) serum asparaginase activity above 0.1 Units/mL with calaspargase pegol-mknl at a dose of 2500 units/m² given intravenously (IV) every 3 weeks.
- Common side effects include: elevated liver enzymes, increased bilirubin, pancreatitis, and abnormal clotting studies.
Posted: December 2018