Monthly News Roundup – December 2018

31/12/2018

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

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