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Adagrasib
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Adagrasib
Clinical data
Trade namesKrazati
Other namesMRTX-849
AHFS/Drugs.comMonograph
MedlinePlusa623003
License data
Routes of
administration		By mouth
Drug classAntineoplastic agent
ATC code
Legal status
Legal status
Identifiers
  • {(2S)-4-[7-(8-chloronaphthalen-1-yl)-2-{[(2S)-1methylpyrrolidin-2-yl]methoxy}-5,6,7,8tetrahydropyrido[3,4-d]pyrimidin-4-yl]-1-(2-fluoroprop2-enoyl)piperazin-2-yl}acetonitrile
CAS Number
PubChem CID
DrugBank
UNII
KEGG
CompTox Dashboard (EPA)
ECHA InfoCard100.329.928 Edit this at Wikidata
Chemical and physical data
FormulaC32H35ClFN7O2
Molar mass604.13 g·mol−1
3D model (JSmol)
  • CN1CCC[C@H]1COC2=NC3=C(CCN(C3)C4=CC=CC5=C4C(=CC=C5)Cl)C(=N2)N6CCN([C@H](C6)CC#N)C(=O)C(=C)F
  • InChI=1S/C32H35ClFN7O2/c1-21(34)31(42)41-17-16-40(18-23(41)11-13-35)30-25-12-15-39(28-10-4-7-22-6-3-9-26(33)29(22)28)19-27(25)36-32(37-30)43-20-24-8-5-14-38(24)2/h3-4,6-7,9-10,23-24H,1,5,8,11-12,14-20H2,2H3/t23-,24-/m0/s1
  • Key:PEMUGDMSUDYLHU-ZEQRLZLVSA-N

Adagrasib, sold under the brand name Krazati, is an anticancer medication used to treat non-small cell lung cancer.[1][2] Adagrasib is an inhibitor of G12C mutated KRAS GTPase.[1] It is taken by mouth.[1] It is being developed by Mirati Therapeutics.[1][5]

The most common adverse reactions include diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation.[2] The most common laboratory abnormalities include decreased lymphocytes, increased aspartate aminotransferase, decreased sodium, decreased hemoglobin, increased creatinine, decreased albumin, increased alanine aminotransferase, increased lipase, decreased platelets, decreased magnesium, and decreased potassium.[2]

It was approved for medical use in the United States in December 2022 for lung cancer[1][2][5][6] and together with Cetuximab in 2024 for colorectal cancer.[7][8]

Medical uses

[edit]

Adagrasib is indicated for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy.[1][2][9]

In June 2024, the US FDA granted accelerated approval to adagrasib plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.[10][11]

History

[edit]

Approval by the US Food and Drug Administration (FDA) was based on KRYSTAL-1, a multicenter, single-arm, open-label clinical trial (NCT03785249) which included participants with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutations.[2] Efficacy was evaluated in 112 participants whose disease has progressed on or after platinum-based chemotherapy and an immune checkpoint inhibitor, given either concurrently or sequentially.[2]

The FDA granted the application for adagrasib fast-track, breakthrough therapy, and orphan drug designations.[2]

Society and culture

[edit]
[edit]

In November 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency, following a re-examination procedure, adopted a positive opinion recommending the granting of a conditional marketing authorization for the medicinal product Krazati, intended for the treatment of people with KRAS G12C mutation non-small cell lung cancer.[12] The applicant for this medicinal product is Mirati Therapeutics B.V.[12]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Adagrasib

View on Grokipedia
from Grokipedia
Adagrasib, sold under the brand name Krazati, is an orally administered small-molecule medication that acts as a selective, irreversible inhibitor of the G12C mutant protein, primarily used to treat advanced cancers driven by this specific genetic alteration, including non-small cell lung cancer (NSCLC) and (CRC). Developed by , Inc., a company, adagrasib covalently binds to the residue at amino acid position 12 in the inactive GDP-bound form of the G12C protein, preventing its activation and subsequent stimulation of downstream signaling pathways such as RAF-MEK-ERK that drive uncontrolled in tumors. This mechanism addresses a historically "undruggable" , with the G12C mutation occurring in about 13% of NSCLC cases and 3-4% of CRC cases, making adagrasib a for these previously challenging subsets of patients. The U.S. (FDA) granted accelerated approval to adagrasib on December 12, 2022, for adult patients with locally advanced or metastatic NSCLC harboring the G12C mutation following at least one prior , based on the phase 2 KRYSTAL-1 trial demonstrating an objective response rate of 43%. On June 21, 2024, the FDA expanded its approval on an accelerated basis for use in combination with for adults with G12C-mutated locally advanced or metastatic CRC after prior fluoropyrimidine-, -, and irinotecan-based , supported by the KRYSTAL-1 trial's combination arm showing a 34% objective response rate (95% CI: 25-45). The recommended dosage is 600 mg taken orally twice daily with or without food until disease progression or unacceptable toxicity.

Pharmacology

Mechanism of action

Adagrasib is a small-molecule covalent inhibitor that irreversibly binds to the residue at position 12 (Cys12) in the GDP-bound form of the G12C mutant protein. This binding occurs via a 2-fluoroacrylamide that forms a stable covalent with the mutant , which is uniquely accessible in the switch-II pocket of the inactive GDP-bound conformation. The G12C mutation, resulting from a glycine-to- substitution at codon 12, is prevalent in approximately 13% of non-small cell (NSCLC) cases and drives oncogenic signaling by promoting constitutive activation of the MAPK pathway, including RAF-MEK-ERK components, leading to uncontrolled . By locking KRAS G12C in its inactive GDP-bound state, adagrasib prevents the exchange of GDP for GTP, thereby inhibiting the conformational switch required for KRAS activation and subsequent of downstream effectors. This disruption halts the propagation of signals through the RAF-MEK-ERK cascade, reducing of ERK and suppressing tumor cell growth in KRAS G12C-mutated cells. The selectivity of adagrasib for G12C over wild-type stems from its structural design, featuring a tetrahydropyridopyrimidine core with specific substituents such as a cyanomethyl group that displaces a molecule near Gly10 and an 8-chloronaphthyl moiety that occupies a hydrophobic subpocket, enabling precise fitting into the mutant-specific pocket while minimizing interactions with the wild-type protein. This targeted binding results in minimal off-target effects on other RAS isoforms or wild-type .

Pharmacokinetics

Adagrasib is rapidly absorbed following , with a time to peak plasma concentration (Tmax) of 6 hours (range: 6–12 hours) following multiple doses of mg twice daily. The drug exhibits high , though exact values are not specified in clinical data. Administration with a high-fat meal does not result in clinically significant changes in . The apparent for adagrasib is 942 L (57% CV), indicating extensive distribution into tissues. It is highly bound to plasma proteins, with approximately 98% binding . Adagrasib undergoes primary metabolism in the liver via enzymes, predominantly following single doses, with contributions from CYP2C8, , , , and at steady state. Major circulating metabolites, such as M68 and M11, are inactive and do not contribute significantly to pharmacological activity. Elimination of adagrasib occurs primarily through fecal excretion, with approximately 75% of the dose recovered in (about 14% as unchanged ) and less than 5% in (about 2% unchanged). The terminal is approximately 23 hours, and apparent oral clearance is around 37 L/h. Steady-state concentrations are achieved within about 8 days of twice-daily dosing. No clinically significant pharmacokinetic differences are observed in patients with mild to severe renal impairment ( clearance 15 to <90 mL/min) or hepatic impairment (Child-Pugh A to C), and no dosage adjustments are required.

Medical uses

Indications

Adagrasib is indicated as a single agent for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior . In the phase 2 portion of the KRYSTAL-1 trial, adagrasib monotherapy demonstrated an objective response rate (ORR) of 43% (95% CI, 34-53) by blinded independent central review in this patient population. In June 2024, the FDA granted accelerated approval to adagrasib in combination with for the treatment of adult patients with G12C-mutated locally advanced or metastatic (CRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, -, and irinotecan-based . This approval was based on data from a cohort of the KRYSTAL-1 , where the combination achieved an ORR of 34% (95% CI, 25-45) by blinded independent central review in 94 previously treated patients. Patient selection for adagrasib therapy requires confirmation of the G12C mutation using FDA-approved companion diagnostic tests, such as the therascreen RGQ PCR Kit for tissue samples or the Agilent Resolution ctDx FIRST Assay for plasma samples in the NSCLC indication. Adagrasib is under investigation in ongoing clinical trials for other G12C-mutated solid tumors, including a phase 1b trial evaluating its monotherapy in metastatic .

Dosage and administration

Adagrasib is administered orally at a recommended dose of 600 mg twice daily, which equates to three 200 mg tablets taken every 12 hours, continuing until disease progression or unacceptable toxicity. This regimen applies both as monotherapy for G12C-mutated non-small cell and in combination with for G12C-mutated . The tablets may be taken with or without food and must be swallowed whole with water to avoid or . If a dose is missed by more than 4 hours, it should be skipped, and the next dose taken at the regularly scheduled time; no additional dose is needed if vomiting occurs after administration. is commonly managed with supportive care, including antiemetics as needed. Dose modifications are recommended for adverse reactions, starting with a reduction to 400 mg twice daily (two 200 mg tablets every 12 hours) for the first step, followed by 600 mg once daily (three 200 mg tablets) if further reduction is required. Therapy should be withheld for severe reactions until resolution to grade 1 or baseline, then resumed at the next lower dose level; permanent discontinuation is advised if the lowest dose (600 mg once daily) is not tolerated or for specific toxicities such as confirmed or with AST/ALT greater than 3 times the upper limit of normal concurrent with greater than 2 times the upper limit of normal. No dosage adjustments are required for patients with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C) or for mild to severe renal impairment ( clearance 15 to less than 90 mL/min). Treatment initiation requires confirmation of G12C mutation in tumor or plasma specimens using an FDA-approved test. Tumor response should be assessed regularly using RECIST version 1.1 criteria to monitor for disease progression.

Adverse effects

Common adverse reactions

In clinical trials, particularly the KRYSTAL-1 study evaluating adagrasib in patients with KRASG12C-mutated non-small cell (NSCLC), the most frequently reported adverse reactions were gastrointestinal in nature, affecting the majority of patients and typically manifesting as mild to moderate (grade 1 or 2) events. These reactions included , , and vomiting, which occurred early in treatment and were generally manageable with supportive care such as antidiarrheals and antiemetics. Other common effects encompassed fatigue and musculoskeletal pain, contributing to overall tolerability but rarely leading to discontinuation. The following table summarizes the incidence of common adverse reactions (occurring in ≥20% of patients) from the KRYSTAL-1 trial (n=116):
Adverse ReactionAny Grade (%)Grade 3 or 4 (%)
700.9
694.3
597
560.9
Musculoskeletal pain417
3710
Renal impairment366
Dyspnea3510
320
Decreased appetite304.3
In the NSCLC cohort, headache occurred in 15% of patients (any grade), typically as a grade 1-2 event without significant impact on treatment continuation. Most common adverse reactions had an onset within the first month of therapy, with gastrointestinal effects typically appearing within the first two cycles and resolving within 2-3 weeks after onset in the majority of cases; they were often self-limiting or responsive to dose interruptions. Laboratory abnormalities were also prevalent, including decreased (51% any grade, 8% grade 3 or 4), increased (ALT; 46% any grade, 5% grade 3 or 4), and increased aspartate aminotransferase (AST; 52% any grade, 6% grade 3 or 4), which generally did not require intervention beyond monitoring. These adverse reactions were associated with mild impacts on patient-reported , with gastrointestinal symptoms and most commonly noted as affecting daily activities, though overall health-related remained stable in the KRYSTAL-1 trial as measured by standardized scales. Supportive measures and dose adjustments helped mitigate disruptions, allowing most patients to continue .

Colorectal cancer

In the KRYSTAL-1 trial for G12C-mutated (CRC), adagrasib in combination with (n=94) showed the following common adverse reactions occurring in ≥20% of patients:
Adverse ReactionAny Grade (%)Grade 3 or 4 (%)
8422
681
654
570
574
Musculoskeletal pain471
3810
370
Dry skin360
304
Decreased appetite300
280
2711
240
250
230
200

Serious adverse reactions

Serious adverse reactions associated with adagrasib occur in approximately 57% of patients treated for non-small cell (NSCLC), with fatal events reported in 11% of cases in clinical trials. These fatal reactions include (3.4%), (1.7%), sudden death (1.7%), cardiac failure (0.9%), cerebrovascular accident (0.9%), mental status changes (0.9%), (0.9%), and (0.9%). In (CRC) patients receiving adagrasib in combination with , one fatal case of was observed among 94 participants. Interstitial lung disease (ILD)/ represents a severe , affecting 4.1% of 366 pooled NSCLC patients, with 1.4% experiencing Grade 3 or 4 severity and one fatal case reported; median onset was 12 weeks. QTc interval prolongation, which may lead to ventricular tachyarrhythmias or sudden death, occurred in 6% of NSCLC patients with QTc ≥501 msec and 11% with an increase >60 msec from baseline. was noted in 37% of NSCLC patients, including 7% with Grade 3 or 4 events and 0.3% with drug-induced (all Grade 3). Other serious reactions in ≥2% of NSCLC patients include (17%), dyspnea (9%), renal impairment (8%), (5%), hypoxia (4.3%), (4.3%), and (4.3%). Management of serious adverse reactions involves dose interruption, reduction, or discontinuation based on severity. For Grade 3 or 4 events, adagrasib should be withheld and resumed at a reduced dose upon recovery to Grade ≤1 or baseline; permanent discontinuation is recommended for recurrent Grade 4 events or persistent Grade 3 events despite dose reduction. Supportive care includes antibiotics for infections such as or , and cardiac monitoring with ECG and electrolyte assessment for QT prolongation. For suspected ILD/, withhold adagrasib and permanently discontinue if confirmed without alternative etiology; (AST, ALT, , total ) should be monitored prior to initiation and monthly for the first 3 months. In CRC combination therapy, discontinuation occurred in 2% of patients due to events like and QT prolongation. The FDA label warns of ILD , recommending evaluation for new or worsening respiratory symptoms and avoidance of concomitant strong inducers, which may reduce adagrasib , or strong inhibitors, which increase exposure and after steady-state achievement (approximately 8 days). Post-marketing surveillance through the FDA Reporting (FAERS) from Q4 2022 to Q1 2025 identified 556 reports for adagrasib, with 36.66% resulting in death and significant signals for respiratory disorders (n=97), infections (n=69), and hepatobiliary issues (n=25); new signals included skin and seizures. An earlier FAERS analysis (September 2022–December 2023) reported life-threatening or fatal outcomes in 42.9% of cases and hospitalization in 41.12%, with signals for renal failure, , and QT prolongation.

History

Development

Adagrasib, initially designated as MRTX849, was developed by Mirati Therapeutics as part of their effort to target the previously undruggable KRAS oncogene, specifically the G12C mutation. The KRAS program at Mirati advanced significantly by late 2017, with the identification of an orally active, mutation-selective clinical lead candidate, leading to plans for an Investigational New Drug (IND) application in 2018. This development built on broader scientific advances in covalent targeting of KRAS G12C, aiming to lock the protein in its inactive GDP-bound state. Preclinical studies demonstrated MRTX849's potent and selective inhibition of KRAS G12C and . In cell line models and patient-derived xenografts harboring G12C mutations across various tumor types, including , colorectal, and pancreatic cancers, MRTX849 induced tumor regression in 65% of cases (17 out of 26 models tested). These studies also highlighted potential resistance mechanisms, such as KRAS nucleotide cycling, activation of receptor tyrosine kinases (RTKs), bypass pathways independent of KRAS, and dysregulation, underscoring the challenges in achieving durable responses and informing strategies for combination therapies. The first-in-human evaluation occurred in the phase 1 portion of the KRYSTAL-1 trial (NCT03785249), initiated on January 15, 2019, which assessed safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with advanced solid tumors carrying G12C mutations. Early data from this trial, presented in October 2019, showed objective responses in patients with non-small cell lung cancer and , establishing a maximum tolerated dose of 600 mg twice daily and supporting further development. Key milestones included Mirati's collaborations for combination approaches, such as with in 2021 to explore adagrasib alongside other KRAS-targeted therapies, addressing resistance observed preclinically. In October 2023, announced its acquisition of for $5.8 billion, which was completed on January 23, 2024, integrating adagrasib into their portfolio and accelerating its expansion into combination regimens with immunotherapies and other targeted agents. These steps overcame historical barriers to targeting by leveraging covalent chemistry and strategic partnerships.

Regulatory approvals

Adagrasib received accelerated approval from the U.S. Food and Drug Administration (FDA) on December 12, 2022, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation following at least one prior systemic therapy. This approval was supported by results from the phase 1/2 KRYSTAL-1 trial, which showed an objective response rate of 42.9% and a median duration of response of 8.5 months in the NSCLC cohort. The indication remains under accelerated approval, with continued authorization contingent on verification of clinical benefit in the ongoing confirmatory phase 3 KRYSTAL-12 trial, which demonstrated improved progression-free survival compared to docetaxel but has not yet led to conversion to full approval as of November 2025. The results, published in August 2025, showed a median progression-free survival of 5.5 months with adagrasib compared to 3.8 months with docetaxel (hazard ratio 0.58, 95% CI 0.46-0.72). On June 21, 2024, the FDA expanded accelerated approval to include adagrasib in combination with for adult patients with G12C-mutated locally advanced or metastatic (CRC) after prior fluoropyrimidine-, -, and irinotecan-based . Efficacy for this indication was evaluated in the CRC cohort of the KRYSTAL-1 , with continued approval pending confirmatory evidence from additional trials. The European Medicines Agency (EMA) granted conditional marketing authorization for adagrasib on January 5, 2024, as monotherapy for adults with advanced NSCLC harboring a KRASG12C mutation who have progressed after prior systemic therapy, including platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy. This authorization was based on clinical data from the KRYSTAL-1 trial demonstrating antitumor activity in this population. Adagrasib has also received regulatory approvals in other regions, including the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) on November 3, 2023, for the same NSCLC indication as the FDA, and Japan's in 2024 for G12C-mutated advanced NSCLC. In , commercialization rights are held by Zai Lab through a partnership with , with a submitted to the in 2024 based on global trial data, though approval status remains pending as of November 2025. No warnings are associated with adagrasib in its approved labels.

Society and culture

Adagrasib is classified as a prescription-only in countries where it has received regulatory approval, such as the , and it is not designated as a under the . Following its accelerated approval by the U.S. (FDA) in December 2022, adagrasib was launched in the for commercial availability. Globally, access is facilitated through strategic partnerships, including a collaboration with Zai Lab for development and commercialization in and other parts of , enabling broader distribution in those regions. In the United States, adagrasib carries a high cost, approximately $23,000 per month, reflecting its status as a targeted therapy. It is covered under plans, which provide prescription drug benefits for eligible beneficiaries, though many insurers, including plans, require to confirm patient eligibility, such as documentation of G12C via FDA-approved testing. The FDA granted designation to adagrasib on June 7, 2021, for the treatment of G12C-positive non-small cell (NSCLC), qualifying it for incentives such as seven years of market exclusivity upon approval, tax credits for , and fee waivers to support development for rare diseases affecting fewer than 200,000 individuals in the U.S. This exclusivity period for the orphan indication extends until December 12, 2029. Adagrasib benefits from patent protection, with the patent set to expire in 2037–2038, providing market exclusivity until that time and limiting opportunities for generic entry until post-patent challenges and regulatory approvals are resolved.

Brand names

Adagrasib is commercially available under the primary brand name Krazati, developed originally by and currently manufactured and distributed by following their acquisition of Mirati in January . In international markets, Krazati is the approved brand name in the , where it received marketing authorization in January 2024. In Greater China, commercialization rights are held by Zai Lab, which may introduce the drug under a local brand name upon regulatory approval. As of November 2025, no generic versions of adagrasib are available, with the first generics anticipated after the expiration of market exclusivity periods granted upon initial approvals. Krazati is supplied as white to off-white, oval-shaped, immediate-release film-coated tablets containing 200 mg of adagrasib, packaged in high-density polyethylene bottles of 180 tablets with child-resistant closures and desiccants.

References

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  23. https://news.bms.com/news/details/2023/Bristol-Myers-Squibb-Strengthens-and-Diversifies-Oncology-Portfolio-With-Acquisition-of-Mirati-Therapeutics/default.aspx
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