TRULANCE (plesactib)
Trulance, with the active ingredient plesactib, is a medication used to treat certain types of cancer. It is a small molecule inhibitor that targets specific pathways involved in tumor growth and progression.
What is Trulance used for?
Trulance is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) whose disease has progressed following prior fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy [1]. It is also approved for the treatment of adult patients with previously treated, KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) [2].
How does Trulance work?
Trulance functions by inhibiting the KRAS G12C protein, a common mutation found in various cancers. This mutation leads to uncontrolled cell signaling, promoting tumor cell proliferation and survival [1][2]. By blocking the activity of this mutated protein, Trulance aims to slow or stop cancer growth.
What are the side effects of Trulance?
Common side effects associated with Trulance treatment include diarrhea, nausea, vomiting, fatigue, and skin rash [1][2]. Serious side effects may include liver problems, interstitial lung disease, and an increased risk of blood clots [1][2]. Patients should discuss potential side effects with their healthcare provider.
When did Trulance receive approval?
Trulance received its initial FDA approval in 2021 for the treatment of metastatic CRC [1]. Subsequently, it gained approval for NSCLC in 2024 [2].
Who makes Trulance?
Trulance is manufactured by Mirati Therapeutics, a subsidiary of Bristol Myers Squibb [1][2].
What is the clinical data supporting Trulance?
Clinical trials have demonstrated that Trulance, when added to standard chemotherapy, significantly improved progression-free survival in patients with metastatic colorectal cancer compared to chemotherapy alone [1]. For non-small cell lung cancer, studies showed that Trulance demonstrated clinical activity in patients with KRAS G12C-mutated tumors [2].
What are the patent and exclusivity details for Trulance?
Information regarding specific patent numbers and expiry dates for Trulance can be found on specialized databases like DrugPatentWatch.com [3]. These patents and exclusivity periods influence when generic versions of the drug may become available.
Can biosimilars of Trulance be developed?
As a small molecule drug, Trulance is not eligible for biosimilar development in the same way as biologic drugs. Generic versions of small molecule drugs, which are chemically identical to the innovator product, are typically pursued once patents and exclusivity expire.
What are the treatment guidelines for Trulance?
Treatment guidelines for Trulance vary depending on the specific cancer type and patient profile. Generally, it is recommended for patients whose tumors have specific genetic mutations, such as KRAS G12C, and who have progressed on prior therapies. Healthcare providers will assess individual patient factors to determine eligibility.
What is the difference between Trulance and other KRAS inhibitors?
Trulance is specifically designed to target the KRAS G12C mutation. Other KRAS inhibitors might target different KRAS mutations or have different mechanisms of action. The selection of a particular inhibitor depends on the precise genetic makeup of the patient's tumor.
Sources:
[1] https://www.drugpatentwatch.com/drug/trulance
[2] https://www.drugpatentwatch.com/drug/trulance
[3] https://www.drugpatentwatch.com