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Monthly News Roundup - November 2018

FDA Approves Truxima as the First Biosimilar to Rituxan

In November, the U.S. Food and Drug Administration (FDA) approved Truxima (rituximab-abbs) injection from Celltrion as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL).

  • Truxima is used as a single agent or in combination with chemotherapy in patients with various grades of NHL, based on previous treatments.
  • Truxima is also the first US biosimilar to be approved for the treatment of non-Hodgkin’s lymphoma.
  • The most common side effects of Truxima include infusion reactions, fever, low level of lymphocytes (a type of white blood cell), chills, infection and weakness (asthenia).

Vitrakvi Gains Accelerated Approval for TRK Fusion Cancers

Vitrakvi, from Loxo Oncology, is used for cancers based on a common gene mutation rather than site of origin in the body.

  • The FDA has approved Vitrakvi (larotrectinib), a treatment for adults and children with various solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.
  • Vitrakvi is taken orally twice daily. In studies of 55 patients, larotrectinib demonstrated a 75% overall response rate across different types of solid tumors. Of those who responded, 73% responded for at least six months, and 39% for at least one year.
  • Common side effects (≥ 20%) included fatigue, nausea, cough, constipation, and diarrhea, among others.

FDA Clears Once-Daily Yupelri for Chronic Obstructive Pulmonary Disease

This month Theravance Biopharma and Mylan N.V. announced the approval of Yupelri (revefenacin), the first once-daily nebulized bronchodilator for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

  • COPD, typically caused by smoking, is the third leading cause of death in the US and affects roughly 16 million Americans at a cost of over $50 billion.
  • Yupelri is a nebulized, long-acting muscarinic antagonist (LAMA), a first-line drug class for COPD. In Phase 3 studies compared to placebo, Yupelri led to significant improvements in lung function (FEV1, OTE FEV1) after 12 weeks of dosing.
  • Common side effects included cough, upper respiratory tract infection, headache, and back pain.

Pfizer’s Daurismo OK’d for Newly-Diagnosed Acute Myeloid Leukemia (AML)

Many adults with AML are unable to have intensive chemotherapy due to toxic effects. In response, the FDA has approved Daurismo (glasdegib), an oral hedgehog pathway inhibitor used with low-dose cytarabine (LDAC) chemotherapy for newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older or if unable to use intensive chemotherapy.

  • AML is a blood and bone marrow cancer that leads to abnormal white blood cells, bruising, fatigue, and infections.
  • In a clinical trial with 111 adult patients, median overall survival (OS) was 8.3 months for patients treated with Daurismo plus LDAC compared with 4.3 months for patients treated with LDAC only.
  • Common side effects included low red blood cell count (anemia), tiredness, bleeding, and muscle pain, among others.

Xospata OK’d for Aggressive Form of Acute Myeloid Leukemia (AML)

The FDA has approved once-daily Xospata (gilteritinib) oral tablets for adults with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Xospata is classified as an inhibitor of tyrosine kinases FLT3/AXL.

  • Xospata, from Astellas, is the first drug to be approved that can be used alone for relapsed or refractory AML with a FLT3 mutation.
  • In studies of 138 patients, 21% percent of patients achieved complete remission or complete remission with partial recovery of blood counts. Of the 106 patients who required blood transfusions, 31% became transfusion-free for at least 56 days.
  • Common side effects were muscle and joint pain, fatigue and elevated liver enzymes.

Firdapse Approved as First Treatment for Rare Autoimmune Disorder

The FDA has approved Firdapse (amifampridine) tablets from Catalyst Pharmaceuticals. Firdapse is used for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults, a very rare autoimmune disorder.

  • In LEMS, the body’s own immune system attacks the connection between nerves and muscles, preventing neuromuscular signals and leading to weakness and fatigue.
  • In two placebo-controlled clinical trials in 64 patients which measured muscle weakness and overall well-being, Firdapse lead to a greater benefit than placebo.
  • Common side effects with Firdapse, a neuronal potassium channel blocker, included burning or prickling sensation (paresthesia), upper respiratory tract infection, and nausea, among several others.

Posted: November 2018