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First approval for cemiplimab-rwlc

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On September 28, 2018, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Cemiplimab-rwlc is the third antibody therapeutic targeting PD1 to be granted an FDA approval, but it is the first drug to be approved in the US specifically for advanced CSCC.

FDA’s approval of Libtayo was based on a combined analysis of data from an open-label, multi-center, non-randomized Phase 2 trial known as EMPOWER-CSCC-1 (Study 1540) and two advanced CSCC expansion cohorts from a multi-center, open-label, non-randomized Phase 1 trial (Study 1423). A total of 108 patients (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation. The confirmed objective response rate for all patients treated with Libtayo was 47%. FDA granted cemiplimab Breakthrough Therapy Designation status for advanced CSCC in 2017, and the drug’s marketing application was granted a priority review.

The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of Sep 28, a total of 11 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 5 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table in either PDF or Excel formats, located in the Members Only section.

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First approval for galcanezumab-gnlm

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On September 28, 2018, the U.S. Food and Drug Administration (FDA) approved galcanezumab-gnlm (Emgality) for the preventive treatment of migraine in adults. Emgality is the third antibody therapeutic approved by FDA in 2018 for this indication. As we reported in previous posts, Aimovig (erenumab-aooe) was approved on May 17, 2018 and Ajovy (fremanezumab-vfrm) was approved on September 14, 2018. The three products target either calcitonin gene-related peptide (CGRP) or the CGRP receptor. The recommended dosage of Emgality is 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg.

The efficacy and safety of Emgality was demonstrated in two Phase 3 clinical trials in patients with episodic migraine (EVOLVE-1, EVOLVE-2) and one Phase 3 clinical trial in patients with chronic migraine (REGAIN). In all three studies, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. In EVOLVE-1, the mean change from baseline (days) was -4.7 days (N=210) for Emgality 120 mg compared to -2.8 days (N=425) for placebo (p<0.001), while in EVOLVE-2, the mean change from baseline (days)was -4.3 days (N=226) for Emgality 120 mg compared to -2.3 days (N=450) for placebo (p<0.001). In the REGAIN study, the mean change from baseline (days) was -4.8 days (N=273) for Emgality 120 mg compared to -2.7 days (N=538) for placebo (p<0.001).

The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of Sep 28, a total of 10 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 6 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table in either PDF or Excel formats, located in the Members Only section.

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First approval for fremanezumab-vfrm

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On September 14, 2018, the U.S. Food and Drug Administration (FDA) approved fremanezumab-vfrm (Ajovy) for the preventive treatment of migraine in adults. The drug may be administered as either 225 mg monthly, or 675 mg quarterly, subcutaneous doses. Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), thereby blocking the binding of the ligand to its receptor. The monoclonal antibody erenumab-aooe (Aimovig), which was approved by the FDA in May 2018 for the preventive treatment of migraine in adults, targets CGRP receptor, rather than the ligand. Marketing applications for galcanezumab, another monoclonal antibody that targets CGRP, are undergoing review by FDA and the European Medicines Agency.

The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of September 14, a total of 9 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 7 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table in either PDF or Excel formats, located in the Members Only section.

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First approval for moxetumomab pasudotox-tdfk

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On September 13, 2018, the U.S. Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxiti) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. The drug is a recombinant immunotoxin targeting CD22 composed of an IgG1 kappa variable fragment fused to a truncated form of Pseudomonas exotoxin PE38. In a pivotal, multicenter, open-label study of moxetumomab pasudotox involving 80 patients (79% males; median age, 60.0 years), the durable complete response (CR) rate was 30%, CR rate was 41%, and the objective response rate (CR and partial response) was 75%. Due to the severity and rarity of the disease, the FDA granted the application Fast Track and Priority Review designations and the molecule received US Orphan Drug designation.

The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of Sep 13, a total of 8 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 8 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table in either PDF or Excel formats, located in the Members Only section.

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First approval for caplacizumab

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On September 3, 2018 Sanofi announced that the European Commission granted a marketing approval for caplacizumab (Cablivi), a bivalent single-domain Nanobody targeting von Willebrand factor, as a treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP). During episodes of this rare, life-threatening blood clotting disorder, microclots can form, leading to low platelet counts, ischemia and organ dysfunction in aTTP patients. Caplacizumab was granted Fast Track designation in the US and orphan drug designations in the US and EU for the treatment of aTTP. The biologics license application (BLA) for caplacizumab is undergoing a priority review at the US Food and Drug Administration (FDA). A first action by FDA is expected by February 6, 2019. Caplacizumab was developed by Ablynx, a Sanofi company.

The approval of caplacizumab in the European Union was based in part on the Phase 3 HERCULES study (NCT02553317), a placebo-controlled, randomized study to evaluate the efficacy and safety of caplacizumab in more rapidly restoring normal platelet counts as a measure of the prevention of further microvascular thrombosis. Positive results from this study were announced in October 2017. The HERCULES study recruited 145 patients with an acute episode of aTTP who were randomized 1:1 to receive either caplacizumab or placebo in addition to standard-of-care treatment, which was daily plasma exchange (PEX) and immunosuppression. Patients were administered a single IV bolus of 10 mg caplacizumab or placebo followed by daily SC dose of 10 mg caplacizumab or placebo until 30 days after the last daily PEX. Depending on the response, the treatment could be extended for additional 7-day periods up to a maximum of 28 days. The primary endpoint (time to platelet count response) and several secondary endpoints of HERCULES study were met. In particular, there was a statistically significant reduction in time to platelet count response, with, at any given time, patients treated with caplacizumab 50% more likely to achieve platelet count response;  a 74% relative reduction in the percentage of patients with aTTP-related death, a recurrence of aTTP, or at least one major thromboembolic event during the study drug treatment period; and a 67% relative reduction in the percentage of patients with aTTP recurrence during the overall study period. A 3-year Phase 3 follow-up study (NCT02878603) of patients who completed the HERCULES study is in progress.

The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of Sep 3, a total of 7 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 9 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table in either PDF or Excel formats, located in the Members Only section.

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