The first biologics approved for the treatment of CIN include Neupogen (filgrastim). It is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology indicated for the treatment of neutropenia. Neupogen was approved back in 1991 in the US. The patent for filgrastim expired in the US in 2013 and Europe in 2006. After that several biosimilar therapies such as Granix, Zarxio/Zarzio, and Nivestym got approval for the treatment of CIN.
Neulasta (pegfilgrastim) got approved in the US in the year 2002. It is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The patent of Neulasta was expired in 2015 and 2017, in the US and Europe, respectively. Neulasta biosimilars available in the US market are Fulphila, Udenyca, Ziextenzo, and Nyvepria (not launched yet).
The prophylactic administration of CSF has provided considerable benefits to patients treated with myelosuppressive chemotherapy and has substantially altered the management of CIN over the last decade. According to the action time, MGFs are classified into long-acting (pegfilgrastim, pegfilgrastim, etc.) and short-acting (filgrastim, lenograstim, etc.).
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Compared with short-acting drugs, long-acting drugs have similar effects, with the advantage of being more convenient to use (a single injection 24–72 h after chemotherapy) and a disadvantage of high cost. Short-acting G-CSF is used commonly to prevent CIN/FN and is the main part of G-CSF’s clinical application. Long-acting G-CSF is increasingly used due to its advantage of easy administration (one subcutaneous administration for every cycle).
Prophylactic G-CSFs are effective and safe for preventing CIN/FN if they are initiated 24–72 h after chemotherapy. With so many novel mechanisms of the emerging assets being tested for CIN, it’s certainly sure that these therapies will boost the upcoming market focusing more on the risk-specific patient population. It is quite clear that after the approval and the consecutive launch of late-phase drugs, the market will face the toughest competition.
It is quite clear that CSFs such as G-CSF and GM-CSF are now an integral part of the prevention of potentially life-threatening FN; however, only G-CSF has US FDA approval for use in CIN. These adjunctive agents accelerate the formation of neutrophils from committed progenitors, thereby reducing the duration and severity of neutropenia. G-CSF is used more frequently than GM-CSF for all of these indications because of fewer associated adverse effects.
Read @ Chemotherapy Induced Neutropenia Market Share
Current American Society of Clinical Oncology (ASCO) guidelines recommends primary prophylaxis, or first cycle use, with CSFs being confined to patients with a ≥40% risk of FN, which may include elderly patients and other high-risk patients. In addition to the risk of FN, primary prophylaxis is considered if the patient has risk factors that place them in the Special Circumstances category.
The unmet need associated with the use of CSFs in cancer chemotherapy is the cost of these agents is extremely high; therefore, pharmacy economic evaluations must show that their use can offset other costs, i.e. hospital costs, for the CSFs to prove themselves as having a cost-benefit. Additionally, continuous efforts in R&D to design and develop new Chemotherapy for the treatment of various cancer types serve as a key factor for the growth of the oncology/cancer drugs market.
In the study by Hashiguchi et al. (2015), broad-spectrum antibiotics such as MEP were used as first-line antibiotics in all cases. In all cases, 8% of cases required second-line antibiotics for persisting intermittent fever, and 4% of cases received an additional antifungal regiment.
Original Source:- Chemotherapy Induced Neutropenia Market Size