Revlimid and Pomalyst milestones
On January 7, 2019, Celgene (CELG) issued a press release announcing its strategy to maximize the commercial potential of its major revenue-earning hemato-oncology assets, Revlimid and Pomalyst, over the next 12 months. According to the press release, the company is anticipating FDA approval for its Revlimid-rituximab combination regimen in the relapsed/refractory indolent lymphoma indication based on favorable results from the Phase 3 AUGMENT trial.
According to the press release, the company is also awaiting the decision from the European Medicines Agency’s Committee for Medicinal Products for Human Use (or CHMP) related to Revlimid, Velcade, and its dexamethasone (or RVd) regimen in the newly diagnosed multiple myeloma indication in 2019.
Finally, according to the press release, the company is also awaiting results from the Phase 3 ROBUST trial evaluating Revlimid with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (or R-CHOP) in newly diagnosed ABC-subtype diffuse large B-cell lymphoma (or DLBCL) in 2019. To know more about Revlimid’s label expansion initiatives, please refer to A Look at Celgene’s Revlimid Label Expansion Initiatives in 2018.
According to the press release, Celgene is expecting regulatory approval for Pomalyst, Velcade, and dexamethasone combination regimen from EMA’s CHMP and Japan Pharmaceuticals and Medical Devices Agency (or PMDA) in the relapsed/refractory multiple myeloma indication in 2019.
In the press release, Celgene reported Revlimid revenues in fiscal 2018 to be around $9.7 billion, which is a YoY rise of 18.48%. The company has forecasted Revlimid’s revenues in fiscal 2019 to be close to $10.8 billion, a YoY rise of 11.34%.
In the press release, Celgene has reported Pomalyst’s revenues in fiscal 2018 to be around $2.0 billion, a YoY rise of 23.91%. The company has forecasted Pomalyst’s revenues in fiscal 2019 to be close to $2.4 billion, a YoY rise of 20.0%.