Brand Name
Tepmetko
Generic Name
Tepotinib
View Brand Information FDA approval date: February 03, 2021
Classification: Kinase Inhibitor
Form: Tablet
What is Tepmetko (Tepotinib)?
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial. TEPMETKO is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Approved To Treat
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Brand Information
TEPMETKO (Tepotinib Hydrochloride)
1INDICATIONS AND USAGE
TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (
2DOSAGE FORMS AND STRENGTHS
Tablets: 225 mg, white-pink, oval, biconvex film-coated tablets with embossment "M" on one side and plain on the other side.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are described in greater detail elsewhere in the labeling:
- Interstitial Lung Disease/Pneumonitis
- Hepatotoxicity
- Pancreatic Toxicity
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to TEPMETKO in 506 patients with solid tumors enrolled in five open-label, single-arm studies receiving TEPMETKO as single agent at a dose of 450 mg once daily. This included 313 patients with NSCLC positive for
The data described below reflect exposure to TEPMETKO 450 mg once daily in 313 patients with metastatic non-small cell lung cancer (NSCLC) with
Serious adverse reactions occurred in 51% of patients who received TEPMETKO. Serious adverse reactions in > 2% of patients included pleural effusion (6%), pneumonia (6%), edema (5%), general health deterioration (3.8%), dyspnea (3.5%), musculoskeletal pain (2.9%), and pulmonary embolism (2.2%). Fatal adverse reactions occurred in 1.9% of patients who received TEPMETKO, including pneumonitis (0.3%), hepatic failure (0.3%), dyspnea from fluid overload (0.3%), pneumonia (0.3%), sepsis (0.3%), and death of unknown cause (0.3%).
Permanent discontinuation due to an adverse reaction occurred in 25% of patients who received TEPMETKO. The most frequent adverse reactions (> 1%) leading to permanent discontinuations of TEPMETKO were edema (8%), pleural effusion (1.6%), and general health deterioration (1.6%).
Dosage interruptions due to an adverse reaction occurred in 53% of patients who received TEPMETKO. Adverse reactions which required dosage interruption in > 2% of patients who received TEPMETKO included edema (28%), increased blood creatinine (6%), pleural effusion (3.5%), nausea (3.2%), increased ALT (2.9%), pneumonia (2.6%), decreased appetite (2.2%), and dyspnea (2.2%).
Dose reductions due to an adverse reaction occurred in 36% of patients who received TEPMETKO. Adverse reactions which required dose reductions in > 2% of patients who received TEPMETKO included edema (22%), increased blood creatinine (2.9%), fatigue (2.2%), and pleural effusion (2.2%).
The most common adverse reactions (≥ 20%) in patients who received TEPMETKO were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes, decreased albumin, decreased sodium, increased gamma-glutamyltransferase, increased amylase, increased lipase, increased ALT, increased AST, and decreased hemoglobin.
Table 2 summarizes the adverse reactions in VISION.
Clinically relevant adverse reactions in < 10% of patients who received TEPMETKO included ILD/pneumonitis, fever, dizziness, pruritus, and headache.
Table 3 summarizes the laboratory abnormalities observed in VISION.
5DESCRIPTION
Tepotinib is a kinase inhibitor. TEPMETKO (tepotinib) tablets for oral use are formulated with tepotinib hydrochloride hydrate. The chemical name for tepotinib hydrochloride hydrate is 3-{1-[(3-{5-[(1-methylpiperidin-4-yl)methoxy]pyrimidin-2-yl}phenyl)methyl]-6-oxo-1,6-dihydropyridazin-3-yl}benzonitrile hydrochloride hydrate. The molecular formula is C
Tepotinib hydrochloride hydrate is a white to off-white powder with a pKa of 9.5.
TEPMETKO is supplied as film-coated tablets containing 225 mg of tepotinib (equivalent to 250 mg tepotinib hydrochloride hydrate). Inactive ingredients in the tablet core are mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, and colloidal silicon dioxide. The tablet coating consists of hypromellose, titanium dioxide, lactose monohydrate, polyethylene glycol, triacetin, and red iron oxides.
6CLINICAL STUDIES
The efficacy of TEPMETKO was evaluated in a single-arm, open-label, multicenter, non-randomized, multicohort study (VISION, NCT02864992). Eligible patients were required to have advanced or metastatic NSCLC harboring
Identification of
Patients received TEPMETKO 450 mg once daily until disease progression or unacceptable toxicity. The major efficacy outcome measure was confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as evaluated by a Blinded Independent Review Committee (BIRC). An additional efficacy outcome measure was duration of response (DOR) by BIRC.
The efficacy population included 164 treatment naïve patients and 149 previously treated patients. The median age was 72 years (range 41 to 94 years); 51% female; 62% White, 34% Asian; 26% had Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 and 74% had ECOG PS 1; 49% never smoked; 81% had adenocarcinoma; 94% had metastatic disease; and 13% had CNS metastases. Amongst previously treated patients, 84% received prior platinum-based chemotherapy.
Efficacy results are presented in Table 4.
7HOW SUPPLIED/STORAGE AND HANDLING
TEPMETKO (tepotinib) tablets: 225 mg tepotinib, white-pink, oval, biconvex film-coated tablet with embossment "M" on one side and plain on the other side.
The blister cards consist of a child-resistant blister foil.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
NDC 44087-5000-3
TEPMETKO
Rx Only
Each tablet contains 225 mg of tepotinib
Each carton contains 3 child resistant blister
30 tablets
EMD
10PRINCIPAL DISPLAY PANEL - 60 Tablet Blister Pack Carton
NDC 44087-5000-6
TEPMETKO
Rx Only
Each tablet contains 225 mg of tepotinib
Each carton contains 6 child resistant blister
60 tablets
EMD
