Rybrevant (amivantamab-vmjw) vs Augtyro (repotrectinib)

Rybrevant (amivantamab-vmjw) is a bispecific antibody approved for the treatment of adult patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Augtyro (repotrectinib), on the other hand, is a tyrosine kinase inhibitor under investigation for the treatment of advanced solid tumors harboring ALK, ROS1, or NTRK1-3 rearrangements, but as of the knowledge cutoff date, it has not received FDA approval. When deciding between these medications, it is crucial to consider the specific genetic alterations of the cancer, the drug's approval status, and the guidance of an oncologist, as Rybrevant is specifically indicated for a certain subset of NSCLC patients, while Augtyro targets different genetic alterations and is not yet approved.

Difference between Rybrevant and Augtyro

Metric	Rybrevant (amivantamab-vmjw)	Augtyro (repotrectinib)
Generic name	Amivantamab-vmjw	Repotrectinib
Indications	Treatment of adults with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations	Investigational, not yet approved; potential treatment for solid tumors with NTRK or ROS1 gene fusions, or with ALK gene rearrangements
Mechanism of action	Bispecific antibody that targets EGFR and MET receptor tyrosine kinases	Tyrosine kinase inhibitor targeting TRK, ROS1, and ALK
Brand names	Rybrevant	Augtyro (proposed/investigational)
Administrative route	Intravenous infusion	Oral
Side effects	Rash, infusion-related reactions, paronychia, musculoskeletal pain, and others	Not fully characterized; likely to include common TKI-related side effects such as fatigue, gastrointestinal symptoms, etc.
Contraindications	None known specifically; use caution in patients with severe hypersensitivity to amivantamab-vmjw or its components	Not fully established; likely to include hypersensitivity to repotrectinib or its excipients
Drug class	Bispecific monoclonal antibody	Tyrosine kinase inhibitor
Manufacturer	Janssen Biotech, Inc.	Turning Point Therapeutics, Inc.

Efficacy

Efficacy of Rybrevant (amivantamab-vmjw) in Lung Cancer

Rybrevant (amivantamab-vmjw) is a bispecific antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. This approval is based on the results of the clinical trial CHRYSALIS, which demonstrated the efficacy of Rybrevant in this patient population. In the trial, Rybrevant showed a significant response rate in patients with EGFR exon 20 insertion-positive NSCLC, indicating its potential as a targeted therapy for this subset of lung cancer patients.

The CHRYSALIS trial reported an objective response rate (ORR) of approximately 40% in patients treated with Rybrevant, with a median duration of response (DoR) of around 11 months. This suggests that Rybrevant can induce a meaningful tumor shrinkage in a considerable proportion of treated patients. Moreover, the median progression-free survival (PFS) was observed to be around 8.3 months, which is notable for patients with EGFR exon 20 insertion mutations who have limited treatment options after first-line therapy.

Efficacy of Augtyro (repotrectinib) in Lung Cancer

Augtyro (repotrectinib) is an investigational, next-generation tyrosine kinase inhibitor (TKI) targeting the tropomyosin receptor kinase (TRK), ROS1, and anaplastic lymphoma kinase (ALK) that is being studied for the treatment of patients with advanced NSCLC harboring ROS1 or NTRK fusions. While Augtyro is not yet approved by the FDA, clinical trials have been conducted to evaluate its efficacy in lung cancer patients with these genetic alterations. The preliminary data from these trials suggest that Augtyro has the potential to be an effective treatment option for patients with NSCLC carrying specific oncogenic drivers.

In early clinical trial results, Augtyro has demonstrated promising antitumor activity with a favorable safety profile in NSCLC patients with ROS1 or NTRK fusions. The ORR for patients with ROS1-positive NSCLC was reported to be high, with durable responses. The data also indicates that Augtyro has intracranial activity, which is particularly important for lung cancer patients who often experience brain metastases. The detailed efficacy data, including ORR, DoR, and PFS, will be crucial in determining Augtyro's role in the treatment landscape for lung cancer and are eagerly awaited by the medical community.

Regulatory Agency Approvals

Rybrevant

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA

Augtyro

Food and Drug Administration (FDA), USA

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