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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Prescription, Nonprescription and Orphan Drugs01:02

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
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Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
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Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Updated: Nov 14, 2025

A Method for Screening and Validation of Resistant Mutations Against Kinase Inhibitors
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Orelabrutinib: First Approval.

Sohita Dhillon1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|March 11, 2021
PubMed
Summary

Orelabrutinib, a targeted Bruton's tyrosine kinase (BTK) inhibitor, has gained its first approval in China for specific B cell malignancies. This marks a significant milestone for the oral medication in treating conditions like mantle cell lymphoma and chronic lymphocytic leukemia.

Area of Science:

  • Oncology
  • Immunology
  • Pharmacology

Background:

  • Bruton's tyrosine kinase (BTK) signaling pathway dysregulation is implicated in B cell malignancies and autoimmune disorders.
  • Orelabrutinib is an oral, potent, irreversible, and selective BTK inhibitor developed by InnoCare Pharma.

Purpose of the Study:

  • To summarize the key developmental milestones of orelabrutinib.
  • To highlight the drug's journey leading to its first regulatory approval.

Main Methods:

  • Review of clinical development data and regulatory submissions for orelabrutinib.
  • Analysis of preclinical and clinical studies investigating BTK inhibition.

Main Results:

  • Orelabrutinib received its first approval in China in December 2020.

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  • Approval was granted for adult patients with relapsed or refractory mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

    • Conclusions:

    • Orelabrutinib's development signifies a therapeutic advancement for patients with specific B cell malignancies.
    • Ongoing clinical trials in the USA and China are expanding the potential indications for orelabrutinib.