INDIA – Dr Reddy’s Laboratories has launched Bortezomib for injection, used to treat certain types of cancer in the US market.
A proteasome inhibitor, Bortezomib for injection is indicated for treatment of multiple myeloma and mantle cell lymphoma.
The Hyderabad-based drug major has launched the product after getting approval from the US Food and Drug Administration (USFDA).
The company’s product is the generic version of Takeda Pharmaceuticals’ Velcade. According to IQVIA Health, Velcade and other generics have sales of around US$1.2 billion in the US.
Dr Reddy’s Bortezomib for Injection, is supplied in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous (SQ) or intravenous (IV) use, it noted.
In other news, Natco Pharma Ltd said its partner Breckenridge Pharmaceutical Inc has received approval from the US health regulator for generic Cabazitaxel intravenous powder used in the treatment of prostate cancer.
A proteasome inhibitor, Bortezomib for injection is indicated for treatment of multiple myeloma and mantle cell lymphoma.
The approval granted by the US Food and Drug Administration to Breckenridge Pharmaceutical Inc’ is for the abbreviated new drug application for Cabazitaxel intravenous powder of strength 60mg/1.5ml (40mg/ml), the company said in a regulatory filing.
It is the generic equivalent of Jevtana Kit of Sanofi.
“Breckenridge and Natco are unable to make further comment regarding the launch date for the product, as that is confidential and cannot be disclosed at this time,” the company said.
Citing industry data, Natco said Jevtana Kit generated annual sales of US$303 million during the 12 months ended May 2022.
In other news, the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended conditional marketing approval to teclistamab (Tecvayli) as a treatment for patients with relapsed/refractory multiple myeloma who have undergone treatment with at least 3 previous therapies, among other therapies.
The three therapies include an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 agent—and who progressed on their last line of treatment, according to a press release from Johnson & Johnson.
Teclistamab is a bispecific antibody, meaning it focuses on two different antigens at the same time. The drug forces the immune system’s T cells to recognize the multiple myeloma cells and become activated against them.
This is the first time the regulatory organization has given a positive opinion to a T-cell redirecting bispecific antibody for adult patients with relapsed/refractory disease.
Bispecific antibodies are a relatively new class of drugs in multiple myeloma. One part of the antibody recognizes an antigen on the patient’s own T cells (such as CD3), and the other part of the antibody recognizes an antigen on the surface of myeloma cells.
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