Lilly, Merck & Co., Pfizer, and Roche Lead New Drug ApprovalsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Lilly, Merck, Pfizer, and Roche.
Editor’s Note: This article is updated on a continuous basis for news announced from Wednesday October 19, 2016 to Tuesday October 25, 2016.
FDA OKs Lilly’s Cancer Drug
The US Food and Drug Administation (FDA) has granted Eli Lilly and Company approval for Lartruvo (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for treating adults with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Lartruvo is a monoclonal antibody and received fast track, orphan drug, and breakthrough therapy designations from the FDA for the STS indication. It was reviewed and approved under the FDA’s accelerated approval program.
Source: Eli Lilly
Merck Gets FDA OK for Anti-Inflammatory Antibody…
Merck & Co. has received approval from the US Food and Drug Administration for Zinplava (bezlotoxumab) Injection 25 mg/mL. Merck anticipates making Zinplava available in the first quarter of 2017.
Zinplava is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence. Zinplava is not indicated for the treatment of CDI. Zinplava is not an antibacterial drug and should only be used in conjunction with antibacterial drug treatment of CDI.
Source: Merck & Co.
…and Gets Approval for New Cancer Drug Indication
Merck & Co. has received approval from the US Food and Drug Administration for a new indication for Keytruda (pembrolizumab), the company’s anti- programmed death receptor-1 (anti-PD-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. In addition, the FDA approved a labeling update to include data from a trial of the drug in the second-line or greater treatment setting for patients with metastatic NSCLC. In metastatic NSCLC, Keytruda is approved for use at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
In the US, Keytruda is indicated for the treatment of patients with unresectable or metastatic melanoma at a dose of 2 mg/kg every three weeks until disease progression or unacceptable toxicity; for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (TPS ≥50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; and for treating patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.
Keytruda is also indicated for treating patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy at a fixed dose of 200 mg every three weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Source: Merck & Co.
Pfizer Gets FDA Approval for Updated Cancer-Drug Labeling
Pfizer and partner Astellas Pharma have received approval from the US Food and Drug Administration (FDA) for a supplemental new drug application to update the US product labeling for Xtandi (enzalutamide) capsules, a drug to treat prostate cancer, to include new clinical data versus bicalutamide from a clinical study. The data demonstrate improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were treated with enzalutamide compared to patients who were treated with bicalutamide.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion on April 1, 2016 recommending approval of a type II variation to include the new data in the European label for Xtandi.
Xtandi capsules is an androgen-receptor inhibitor that was approved by the US FDA in 2012 for treating patients with metastatic castration-resistant prostate cancer.
Pfizer gained Xtandi with its $14-billion acquisition of Medivation, a San Francisco-based biopharmaceutical company, which Pfizer completed in September 2016. Pfizer agreed to acquire Medivation in August 2016 for $81.50 a share in cash or approximately $14 billion.
Medivation entered an agreement with Astellas Pharma in 2009 to develop Xtandi globally and commercialize jointly in the US. Xtandi is a top-selling drug with approximately $2.2 billion in worldwide net sales over the past four quarters as recorded by Astellas Pharma.
Medivation and Astellas are continuing a development program for Xtandi, including two Phase III studies in non-metastatic prostate cancer and another Phase III study in hormone-sensitive prostate cancer. It is also being further developed in Phase II studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma.
FDA OKs Roche’s Immunotherapy Drug for Lung Cancer
The US Food and Drug Administration (FDA) has approved Roche’s Tecentriq (atezolizumab) for treating metastatic non-small cell lung cancer (NSCLC) in patients who have disease progression during or following platinum-containing chemotherapy and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
The Tecentriq development program includes more than 15 clinical trials in lung cancer, including seven Phase III studies in previously untreated (first-line) lung cancer. These studies are evaluating the use of Tecentriq alone or in combination with other medicines.
Tecentriq is a monoclonal antibody designed to target and bind to a protein called programmed death ligand-1 PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells. It is currently only approved in the US, according to Roche.