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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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...
Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

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...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

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,...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).

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A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells
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Tarlatamab: First Approval.

Sohita Dhillon1

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

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|July 18, 2024
PubMed
Summary
This summary is machine-generated.

Tarlatamab is a new bispecific antibody for extensive stage small cell lung cancer (SCLC). It targets delta-like ligand 3 (DLL3) and CD3 T-cells, leading to tumor cell death and receiving US approval.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Drug Development

Background:

  • Small cell lung cancer (SCLC) has limited treatment options for extensive stage disease.
  • Delta-like ligand 3 (DLL3) is a target expressed on SCLC cells.
  • T-cell engagers offer a novel approach to cancer immunotherapy.

Purpose of the Study:

  • To summarize the development milestones of tarlatamab.
  • To highlight the first approval of tarlatamab for extensive stage SCLC (ES-SCLC).

Main Methods:

  • Tarlatamab is a bispecific antibody engaging CD3 T-cells with DLL3-expressing tumor cells.
  • Phase 2 DeLLphi-301 study evaluated tarlatamab in patients with ES-SCLC.
  • Mechanism involves T-cell activation and cytokine release, leading to tumor cell death.

Main Results:

  • Tarlatamab received US accelerated approval in May 2024 for adults with ES-SCLC.
  • Approval was based on overall response rate and duration of response from the DeLLphi-301 study.
  • Regulatory reviews are ongoing in other countries, with clinical studies in progress.

Conclusions:

  • Tarlatamab represents a first-in-class therapy for relapsed/refractory ES-SCLC.
  • The drug's mechanism targets DLL3 on tumor cells and CD3 on T-cells.
  • Continued clinical trials are necessary to confirm clinical benefit.