Top 3 approvals in oncology in October
Across the month of October, we have witnessed three significant approvals in the field of oncology; helping to push forward the diagnostic and treatment options for patients. Check out our roundup below to find out about the US approval of a novel treatment for multiple myeloma and a diagnostic test for breast cancer, as a well key endorsement in Canada for pembrolizumab.
PATHWAY anti-HER2 (4B5) test
Approved: 5 October 2022
Approving body: US FDA
Indication: Metastatic breast cancer patients with low HER2 expression
A targeted treatment, termed Enhertu® (fam-trastuzumab deruxtecan-nxki), can improve the outcomes for patients with metastatic patients who express low levels of HER2. This month, the US FDA approved a companion diagnostic test that can detect HER2 low status in these patients, making them eligible for treatment with Enhertu.
The latest development in the PATHWAY anti-HER2 (4B5) test is the addition of a scoring algorithm that helps pathologists to identify “low expressors” of HER2. The test was used as a part of the DESTINY-Breast04 trial, which reported a 50% reduction in the risk of disease recurrence or death and an overall gain of 6 months over standard of care in patients treated with Enhertu whose tumours had low levels of HER2 expression.
Keytruda® (pembrolizumab)
Approved: 12 October 2022
Approving body: Health Canada
Indication: Renal cell carcinoma subtype
In the middle of the month, Canada followed in the steps of Europe and the US by approving pembrolizumab for the adjuvant treatment of adults with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.
The approval is based on the results from the Phase III KEYNOTE-564 trial, which demonstrated a statistically significant improvement in disease-free survival for patients randomized to receive pembrolizumab monotherapy compared with patients randomized to placebo.
Source: www.merck.ca/en/newsroom/monotherapy-for-the-adjuvant-treatment-of-adults/
Tecvayli™ (teclistamab-cqyv)
Approved: 25 October 2022
Approving body: US FDA
Indication: Multiple myeloma
The final approval of the month ushered in a win for Janssen when the US FDA approved Tecvayli™ -an off-the-shelf, subcutaneous therapy for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy. This is the fourth approval Janssen has received in the multiple myeloma sphere.
The approval, which is based on data from the Phase IIMajesTEC-1 clinical trial, comes with a boxed warning for Cytokine Release Syndrome (CRS) and Neurologic Toxicity. This drug was approved by the EMA earlier this year.
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In other news this month, NICE developed a medtech innovation briefing on Signatera, which is used to detect the presence of molecular residual disease from solid tumours. At the time of writing the experts advised that gaps in evidence mean that there is not enough evidence to support the routine use of the technology in the NHS – however, watch this space as several trials are looking to close the knowledge gaps!
NICE also published guidance for companies on how to use MagTrace and Sentimag to detect sentinel lymph nodes for cancer. Oncology Central previously covered the initial approval of these diagnostic tools, check out our coverage here >>>.
Lastly, researchers from the Institute of Cancer Research made great strides in developing a liquid biopsy test to detect rhabdomyosarcoma in children. Read the full news story here >>>.