The FDA has approved trilaciclib (Cosela, G1 Therapeutics) as the first therapy in its class to protect bone marrow in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.
Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting the enzyme cyclin-dependent kinase 4/6, drug approval agency said in a press release.
Related: New Cabometyx-Opdivo combo for renal cell carcinoma treatment
“For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time and according to plan,” said Albert Deisseroth, M.D., Ph.D., supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research.
Cosela is expected to be commercially available through G1’s specialty distributor partner network in early March, according to a press release issued by the drug's marker, G1 Therapeutics in Research Triangle Park, North Carolina.
The most serious and life-threatening side effect of chemotherapy is myelosuppression, or damage to the bone marrow, resulting in reduced white blood cells, red blood cells and platelets, said Jeffrey Crawford, M,D., Geller Professor for Research in Cancer in the Department of Medicine and Duke Cancer Institute.
Related: FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment
“Chemotherapy-induced myelosuppression may lead to increased risks of infection, severe anemia, and/or bleeding. These complications impact patients’ quality of life and may also result in chemotherapy dose reductions and delays,” Crawford said.
Treatment approaches to date have included the use of growth factor agents to accelerate blood cell recovery after the bone marrow injury has occurred, along with antibiotics and transfusions as needed, according to Crawford.
Cosela is administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy.
Jack Bailey
“Chemotherapy is the most effective and widely used approach to treating people diagnosed with extensive-stage small cell lung cancer; however, standard of care chemotherapy regimens are highly myelosuppressive and can lead to costly hospitalizations and rescue interventions,” said Jack Bailey, CEO of G1 Therapeutics, said in a press release. “COSELA will help change the chemotherapy experience for people who are battling ES-SCLC (extensive-stage small cell lung cancer."
The approval of the new treatment is based on data from three randomized, placebo-controlled trials that showed patients receiving Cosela prior to the start of chemotherapy had clinically meaningful and statistically significant reduction in the duration and severity of neutropenia.
The drug also produced a positive impact on red blood cell transfusions and other myeloprotective measures. The trials evaluated Cosela in combination with carboplatin/etoposide (plus or minus the immunotherapy atezolizumab) and topotecan chemotherapy regimens.
Read more: New lung cancer treatment launches
Iowa Expands PBM Legislation to Address Concerns of Independent Pharmacies
May 16th 2025A new law in Iowa, if signed by the governor, will mandate 100% pass-through of rebates, increased financial transparency, and a minimal payment for pharmacies. Critics say it will be the most costly mandate in the state’s history.
Read More
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
Listen
Survey Reveals Cancer Doctors Struggle to Keep Up as Treatments Advance Quickly
May 11th 2025A new survey by Johnson & Johnson revealed that oncologists are overwhelmed by the rapid pace of innovation in cancer care, with many calling for better tools, education and collaboration to help integrate new treatments and technologies into everyday practice.
Read More
Is Arkansas’ New PBM Law the Right Path Forward for Reform? No One Knows Yet
May 9th 2025It could improve access to community pharmacies and lower prices. Or it will limit access to critical drugs and impact payers’ ability to contract for a broad range of services. Industry leaders are unsure about the impact of Arkansas’ law banning PBMs from owning pharmacies.
Read More