Trilaciclib: Difference between revisions

| pronounce = {{IPAc-en|ˌ|t|r|aɪ|l|ə|ˈ|s|aɪ|k|l|ɪ|b}}<br />{{respell|TRY|lə|SY|klib}}

| Drugs.com = {{drugs.com|pro|Cosela}}

| ATCvet ATC_prefix = V03

| ATC_prefixATC_suffix = NoneAF12

| legal_US_comment = <ref name="Cosela FDA label">{{cite web | title=Cosela- trilaciclib injection, powder, lyophilized, for solution | website=DailyMed | url=https://wwwdailymed.g1therapeuticsnlm.comnih.gov/cosela/pidailymed/drugInfo.cfm?setid=4b06922c-498d-4871-a037-84a44e6a6b6c | access-date=17 June 2021}}</ref><ref name="FDA PR" />

'''Trilaciclib''', sold under the brand name '''Cosela''', is a [[medication]] used to reduce the frequency of chemotherapy-induced [[bone marrow suppression]].<ref name="Cosela FDA label" /><ref name="FDA PR">{{cite press release | title=FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy | website=U.S. [[Food and Drug Administration]] (FDA) | date=12 February 2021 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-drug-reduce-bone-marrow-suppression-caused-chemotherapy | access-date=12 February 2021}} {{PD-notice}}</ref><ref>{{cite press release | title=FDA Approves G1 Therapeutics’Therapeutics' Cosela (trilaciclib): The First and Only Myeloprotection Therapy to Decrease the Incidence of Chemotherapy-Induced Myelosuppression | publisher=G1 Therapeutics | via=GlobeNewswire | date=12 February 2021 | url=https://www.globenewswire.com/news-release/2021/02/13/2175184/0/en/FDA-Approves-G1-Therapeutics-COSELA-trilaciclib-The-First-and-Only-Myeloprotection-Therapy-to-Decrease-the-Incidence-of-Chemotherapy-Induced-Myelosuppression.html | access-date=12 February 2021}}</ref><ref name="Dhillon_2021">{{cite journal | vauthors = Dhillon S | title = Trilaciclib: First Approval | journal = Drugs | volume = 81 | issue = 7 | pages = 867–874 | date = May 2021 | pmid = 33861388 | doi = 10.1007/s40265-021-01508-y | s2cid = 233258487 }}</ref>

Trilaciclib may help protect bone marrow cells from damage caused by chemotherapy by inhibiting [[cyclin-dependent kinase]] 4/6, a type of enzyme.<ref name="FDA PR" /> Trilaciclib is the first therapy in its class and was approved for medical use in the United States in February 2021.<ref name="FDA PR"/><ref>{{cite web | title=Drug Approval Package: Cosela | website=U.S. [[Food and Drug Administration]] (FDA) | date=12 March 2021 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214200Orig1s000TOC.cfm | access-date=13 September 2021}}</ref> The U.S. [[Food and Drug Administration]] considers it to be a [[first-in-class medication]].<ref name="New Drug Therapy Approvals 2021">{{cite report | title=Advancing Health Through Innovation: New Drug Therapy Approvals 2021 | website=U.S. [[Food and Drug Administration]] (FDA) | date=13 May 2022 | url=https://www.fda.gov/media/155227/download | format=PDF | access-date=22 January 2023 | archive-date=6 December 2022 | archive-url=https://web.archive.org/web/20221206210020/https://www.fda.gov/media/155227/download | url-status=live }} {{PD-notice}}</ref>

Chemotherapy drugs are designed to kill cancer cells but can damage normal tissues as well.<ref name="FDA PR" /> The [[bone marrow]] is particularly susceptible to chemotherapy damage.<ref name="FDA PR" /> The [[bone marrow]] makes red blood cells, white blood cells, and platelets (small fragments in the blood) that transport oxygen, fight infection, and stop bleeding.<ref name="FDA PR" /> When damaged, the bone marrow produces fewer of these cells, leading to fatigue, increased risk of infection, and bleeding, among other problems.<ref name="FDA PR" /> Trilaciclib may help protect the normal bone marrow cells from the harmful effects of chemotherapy.<ref name="FDA PR" />

Trilaciclib is [[Indication (medicine)|indicated]] to reduce the frequency of chemotherapy-induced [[bone marrow suppression]] in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) [[small cell lung cancer]].<ref name="Cosela FDA label" /><ref name="FDA PR" />

The effectiveness of trilaciclib was evaluated in three randomized, double-blind, placebo-controlled studies in participants with extensive-stage [[small cell lung cancer]].<ref name="FDA PR" /> Combined, these studies randomly assigned 245 participants to receive either an infusion of trilaciclib in their veins or a placebo before chemotherapy.<ref name="FDA PR" /> The studies then compared the two groups for the proportion of participants with severe [[neutropenia]] (a very low count of white blood cells called neutrophils) and the duration of severe [[neutropenia]] in the first cycle of chemotherapy.<ref name="FDA PR" /> In all three studies, participants who received trilaciclib had a lower chance of having severe [[neutropenia]] compared to participants who received a [[placebo]].<ref name="FDA PR" /> Among those who had severe [[neutropenia]], participants who received trilaciclib, on average, had it for a shorter time than participants who received a [[placebo]].<ref name="FDA PR" />

The U.S. [[Food and Drug Administration]] (FDA) granted the application for trilaciclib [[priority review]] and [[breakthrough therapy]] designations.<ref name="FDA PR" /> The FDA granted the approval of Cosela to [[G1 Therapeutics]], Inc.<ref name="FDA PR" />