Monthly News Roundup - November 2018

- Dec 03, 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