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Monthly News Roundup - September 2018

Ajovy for Migraine Prevention Cleared With Two Dosing Options

Ajovy (fremanezumab-vfrm), an injectable migraine preventive for adults was FDA-approved this month. From Teva, it is the second approved migraine preventive that targets the calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks, and prevents receptor site binding. Ajovy is given as a 225 mg once monthly subcutaneous (under the skin) injection or as a 675 mg injection once every 3 months (quarterly). In studies, the most common side effect (>5%) was injection site reactions. Aimovig (erenumab-aooe), from Amgen, was the first approved CGRP antagonist for migraine prevention and is given monthly.

Lilly’s Emgality is Third Approval in New Class for Migraine Prevention

Eli Lilly’s Emgality (galcanezumab-gnlm) is now the third FDA-approved calcitonin gene-related peptide (CGRP) antagonist for the preventive treatment of migraine in adults, along with the previously approved Ajovy and Aimovig. Dosing for Emgality is 120 mg given once monthly by subcutaneous (under the skin) injection after an initial, one-time, 240 mg loading dose. In Phase 3 studies, the primary endpoint was the mean change in the number of monthly migraine headache days (MHDs) from baseline. Statistically significant reductions ranged from 4.3 to 4.8 fewer MHDs compared to 2.3 to 2.8 fewer MHDs with placebo. Injection site reactions are a common side effect.

Pfizer’s Vizimpro Ok’d as First Line Treatment for Lung Cancer

This month, the FDA approved Vizimpro (dacomitinib), an oral, once-daily kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). Vizimpro targets two lung cancer biomarkers: epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, both detected by an FDA-approved test. In the Phase 3 ARCHER 1050 trial, 452 eligible patients were randomized 1:1 to Vizimpro or Iressa (gefitinib). The major efficacy outcome measure, progression-free survival (PFS), was met with a median of 14.7 months for Vizimpro compared with 9.2 months in the gefitinib arm.

FDA Approves Libtayo for Advanced Squamous Cell Skin Cancer

In September the FDA approved Sanofi/Regeneron’s Libtayo (cemiplimab-rwlc) intravenous injection for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation. Libtayo is classified as a PD-1 blocking antibody (immune checkpoint inhibitor) and is the first approval of a drug specifically for advanced CSCC. In clinical trials, the objective response rate (percent of patients with partial or complete reduction of tumor) was the primary endpoint. Over 47% of patients treated with Libtayo had their tumors shrink or disappear. Common side effects include fatigue, rash and diarrhea.

First-in-Class Copiktra Approved for Slow-Growing Non-Hodgkin Lymphomas

The FDA has approved Copiktra (duvelisib), an oral phosphoinositide 3-kinase (PI3K) inhibitor from Verastem Oncology. Copiktra is the first dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes that boost survival of malignant B-cells. It is indicated for two types of blood cancers in adults after at least two prior therapies: relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL). CLL/SLL and FL are both common types of indolent (slow-growing) non-Hodgkin lymphomas. Labeling for Copiktra contains a Boxed Warning for four serious, possibly fatal toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.

First-In-Class Lumoxiti is FDA-Approved for Hairy Cell Leukemia (HCL)

Hairy cell leukemia (HCL) is a rare blood cancer resulting in too many B cells (lymphocytes), a type of white blood cell that fights infection. The FDA has now approved AstraZeneca’s Lumoxiti (moxetumomab pasudotox-tdfk) intravenous injection for adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including a purine nucleoside analog. Lumoxiti is a first-in-class CD22-directed cytotoxin. In studies, 75% of patients receiving Lumoxiti achieved an overall response, and 30% exhibited a durable complete response (CR), defined as maintenance of hematologic remission for more than 180 days after achievement of CR.

Posted: September 2018

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