This week the FDA and European Commission were quite active. Pfizer (PFE - Free Report) announced FDA approval for its biosimilar version of Roche’s (RHHBY - Free Report) breast cancer medicine, Herceptin while Merck (MRK - Free Report) and Roche gained approval in EU to expand labels of their marketed drugs, Keytruda and Hemlibra, respectively. Meanwhile, the FDA granted a 10-month review period to Allergan’s (AGN - Free Report) regulatory application for key pipeline candidate ubrogepant while J&J (JNJ - Free Report) filed an application with the same authority looking for approval of its multiple myeloma drug , Darzalex in an expanded patient population.
Recap of the Week’s Most Important Headlines
Pfizer’s Biosimilar Herceptin Gets FDA Approval: The FDA approved Pfizer’s Trazimera, a biosimilar version Roche’s breast cancer drug, Herceptin. Trazimera is already approved in the EU. Pfizer’s biosimilar versions of Roche’s other cancer drugs Rituxan and Avastin (Zirabev) are also under review in the United States with FDA decisions on all expected in 2019.
Pfizer and partner Merck KGaA announced that its regulatory filing in the EU looking for approval of Bavencio (avelumab), in combination with Inlyta (axitinib) for advanced renal cell carcinoma (“RCC”), was validated for review by the European Medicines Agency. A similar application is under priority review in the United States with the FDA’s decision expected in June. The regulatory filings in the EU and the United States were based on interim data from the phase III JAVELIN Renal 101 study, which evaluated the Bavencio/Inlyta combination against Pfizer’s older kidney cancer drug, Sutent.
EU Nod to Merck’s Keytruda Combo in Difficult Lung Cancer: Merck announced that the European Commission granted marketing approval to Keytruda, in combination with chemotherapy, as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC – a difficult-to-treat lung cancer patient population. The filing was based on data from the phase III KEYNOTE-407 study. In the United States, a similar label expansion was approved in early October last year.
Roche’s Hemlibra Gets EU Approval in an Expanded Patient Population: The European Commission granted approval to Roche’s regulatory application seeking approval of its drug, Hemlibra for the treatment of hemophilia A patients (adults and children) without factor VIII inhibitors. Hemlibra is presently marketed in the EU for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in haemophilia A patients with factor VIII inhibitors. Hemlibra is now the only haemophilia A treatment approved for patients with and without factor VIII inhibitors that can be administered subcutaneously at multiple dosing options (once weekly, every two weeks, or every four weeks). Hemlibra was approved for a similar indication in the United States in October last year.
FDA Accepts Allergan’s NDA for Ubrogepant: Allergan’s new drug application looking for approval of ubrogepant, its oral anti-CGRP acute migraine treatment, was accepted for review by the FDA. The FDA granted the application a normal review period of 10 months and will give its decision in the fourth quarter of 2019. If approved, ubrogepant would be the first oral CGRP antibody to get approval for migraine and may be used in conjunction with other available migraine treatment.
J&J Files sBLA for Darzalex: J&J filed a supplemental biologics license application (sBLA) seeking approval for its immunotherapy, Darzalex in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone in newly-diagnosed, transplant ineligible multiple myeloma patient population. The filing was based on data from a phase III MAIA study.
Lilly’s Cyramza Meets Primary Endpoint in First-Line Lung Cancer Study: Lilly’s (LLY - Free Report) phase III RELAY study evaluating Cyramza in first-line EGFR mutation positive NSCLC met the primary endpoint of progression-free survival (PFS). The data from the study showed that treatment with Cyramza in combination with erlotinib significantly delayed disease progression in previously untreated patients with metastatic NSCLC whose tumors have activating EGFR mutations. Detailed efficacy and safety results from the study will be presented at a future medical meeting. Lilly intends to initiate global regulatory submissions in mid-2019. Cyramza is presently approved for second-line treatment of advanced/metastatic gastric cancer, metastatic NSCLC and metastatic colorectal cancer.
The NYSE ARCA Pharmaceutical Index rose% in the last five trading sessions.
It was a mixed performance in the last five trading sessions. While AstraZeneca recorded the highest gain of 1.5%, Bristol-Myers (BMY - Free Report) declined the most (3.1%).
In the past six months, Lilly has been the biggest gainer (16.4%) while Bristol-Myers declined the most (18.6%).
(See the last pharma stock roundup here: FDA Ok’s J&J Antidepressant, CHMP Recommends Several Drugs)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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