MedPath

Ripretinib

Generic Name
Ripretinib
Brand Names
Qinlock
Drug Type
Small Molecule
Chemical Formula
C24H21BrFN5O2
CAS Number
1442472-39-0
Unique Ingredient Identifier
9XW757O13D
Background

Ripretinib is a kinase inhibitor used for the treatment of advanced gastrointestinal stromal tumor (GIST) that has not adequately responded to other kinase inhibitors such as sunitinib and imatinib. Ripretinib, also known as Qinlock, is manufactured by Deciphera Pharmaceuticals and was initially approved by the FDA on May 15, 2020.

It is the first drug approved as a fourth-line therapy in the specific setting of prior treatment with a minimum of 3 other kinase inhibitors.

Indication

Ripretinib is indicated to treat adults diagnosed with advanced gastrointestinal stromal tumor (GIST) who have had prior therapy with at least 3 kinase inhibitors, including with imatinib.

Associated Conditions
Advanced Gastrointestinal Stromal Tumor (GIST)

Scotland Approves New Cancer Treatments for Prostate and Liver Cancers

• The Scottish Medicines Consortium (SMC) has approved talazoparib (Talzenna) in combination with enzalutamide for treating adults with prostate cancer, offering a targeted oral therapy option. • Cabozantinib (Cabozantinib Ipsen) has been accepted for treating adults with hepatocellular carcinoma (HCC) who have received previous treatment, expanding options for liver cancer patients. • The SMC rejected two other medications: ripretinib (Qinlock) for gastrointestinal stromal tumors and spesolimab (Spevigo) for generalised pustular psoriasis, citing cost-effectiveness and evidence uncertainties.

FDA Approves Vimseltinib for Tenosynovial Giant Cell Tumor Treatment, Showing 40% Response Rate

• The FDA has granted approval to vimseltinib (DCC-3014) for treating symptomatic tenosynovial giant cell tumor (TGCT), based on positive Phase 3 MOTION trial results. • The pivotal MOTION study demonstrated a significant 40% objective response rate for vimseltinib compared to 0% for placebo, with notable improvements in patient mobility and pain. • The twice-weekly oral medication showed a manageable safety profile, with mostly grade 1-2 adverse events, providing a new therapeutic option for TGCT patients.

Deciphera's Qinlock Fails Phase 3 Trial in Second-Line GIST, Shares Plummet 75%

• Deciphera Pharmaceuticals' Qinlock failed to outperform Pfizer's Sutent in second-line gastrointestinal stromal tumor treatment, with progression-free survival of 8.0 versus 8.3 months respectively. • The disappointing INTRIGUE trial results severely impact Qinlock's projected blockbuster potential, previously estimated at $1.5 billion in annual sales. • Currently approved as a fourth-line therapy, Qinlock generates modest quarterly sales of around $20 million, with a pending European approval offering limited upside potential.

Zai Lab's Augtyro Included in China's National Reimbursement Drug List for ROS1+ NSCLC

• Zai Lab's Augtyro (repotrectinib) has been added to China's National Reimbursement Drug List (NRDL) for treating adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). • The NRDL update also includes the renewal of Nuzyra (omadacycline) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). • Qinlock (ripretinib) is also renewed for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors. • The inclusion of these drugs in the NRDL aims to improve patient access to innovative treatments at more affordable costs throughout China.
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