What We're Reading: Second Person Cured of HIV Speaks Out; BMS' MM Therapy Fails Study; FDA to Review Biosimilar Bevacizumab

March 9, 2020

A year after being only the second person to be cured of HIV, the “London Patient” revealed his identity; BMS announced today that its combination therapy for multiple myeloma—elotuzumab, lenalidomide, and dexamethasone—failed its primary endpoint of progression-free survival in its phase 3 ELOQUENT-1 trial; Biocon and Mylan N.V. announced that the FDA accepted their biologics license application (BLA) for MYL-14020, a proposed biosimilar to bevacizumab (Avastin), for review.

Second Individual Cured of HIV Reveals Identity

A year after being only the second person to be cured of HIV, Adam Castillejo, known as the “London Patient,” revealed his identity stating, “I want to be an ambassador of hope.” According to The New York Times, Castillejo had been diagnosed with HIV in 2003 and had gone through nearly a decade of grueling treatments for the disease. Last March, scientists announced that Castillejo had been cured of HIV after receiving a bone-marrow transplant intended for his lymphoma. However, the donor who provided the transplant carried a mutation that impeded the ability of HIV to enter cells, subsequently causing his immune system to become resistant to the virus.

Bristol Myers Squibb’s MM Combo Therapy Fails to Meet Primary End Point

FDA Accepts BLA for Mylan, Biocon Proposed Biosimilar Bevacizumab

Bristol Myers Squibb Co (BMS) announced today that its combination therapy for multiple myeloma (MM) failed its primary end point in the phase 3 ELOQUENT-1 trial of improving progression-free survival (PFS) in newly diagnosed patients, according to Reuters. BMS’ combination MM therapy, elotuzumab (Empliciti), lenalidomide (Revlimid), and dexamethasone, failed to show a significant PFS improvement in patients when compared with a combination of lenalidomide and dexamethasone.Biocon and Mylan N.V. announced that the FDA accepted has accepted Mylan’s biologics license application (BLA) for MYL-1402O, a proposed biosimilar to bevacizumab (Avastin), for review. The BLA seeks approval of bevacizumab for first-line and second-line treatments of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, first-line use for patients with nonsquamous non—small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa, and persistent, recurrent, or metastatic cervical cancer. The FDA gave the application a decision date of December 27, 2020, according to The Center for Biosimilars.