The end of the year typically brings a number of FDA approvals, and 2023 is no different. Last week, the Food and Drug Administration approved a new drug, Augyro (repotrectinib) for the treatment of patients with ROS1-positive non-small cell lung cancer.
Also making oncology headlines this week, is an expert update on the cancer drug shortage, research about how the severity of diabetes can impact colorectal cancer outcomes and how vitamin D may be able to mitigate the severity of chemotherapy-induced peripheral neuropathy.
- 01:15 FDA Approves Augtyro for Patients With NSCLC Subset
- 02:08 FDA Approves Keytruda plus Chemo for Advanced HER2-Negative Gastric, GEJ Cancers
- 02:48 FDA Approves Truqap Plus Chemo for Some With HR-Positive, HER-Negative Breast Cancer
- 03:28 FDA Approves Xtandi for High-Risk Prostate Cancer
- 05:02 Drug Shortages Continue to Be a ‘Serious Problem’ in Oncology
- 06:56 Diabetes Severity Associated With Poor Colorectal Cancer Survival
- 07:50 Vitamin D May Help Prevent Chemo-Induced Neuropathy
FDA Approves Augtyro for Patients With NSCLC Subset
Another week, another FDA approval. This time, the agency approved Augtyro for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
The drug works by targeting ROS1 oncogene fusions, which can be responsible for the growth of cancer. The approval was based off findings from the phase 1/2 TRIDENT-1 clinical trial, which showed that 79% of patients responded to therapy with the drug, including 6% who experienced a complete response, which is when all signs of cancer disappear.
Bristol Myers Squibb, the pharmaceutical company that manufacturers Augtyro, expects the drug to be available to patients in mid-December.
FDA Approves Keytruda plus Chemo for Advanced HER2-Negative Gastric, GEJ Cancers
Also in FDA news last week, the agency approved the immunotherapy drug, Keytruda, in combination with chemotherapy for the treatment of patients with advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
The approval came after findings from the KEYNOTE-859 trial showed that the immunotherapy-chemo combination improved overall survival) that’s time from treatment until death of any cause); progression-free survival (time from treatment until death or disease worsening) and response rate compared to a group that received placebo plus chemotherapy.
FDA Approves Truqap Plus Chemo for Some With HR-Positive, HER-Negative Breast Cancer
Additionally, the FDA has approved Truqap with chemotherapy fulvestrant for the treatment of adults with HR-positive or HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations and who have progressed on at least one endocrine-based regimen in the metastatic setting or recurred at or within one year of completing adjuvant therapy. And now this approval was based on the results of the CAPItello-291 trial
where among patients with these altered tumors, the median progression free survival was 7.3 months in the Truqap and chemotherapy cohort and 3.1 months in the placebo and chemotherapy cohort.
FDA Approves Xtandi for High-Risk Prostate Cancer
And the FDA approved Xtandi for the treatment of patients with non-metastatic castration-sensitive prostate cancer, with a high risk of biochemical recurrence, meaning a recurrence that is determined by rising prostate specific antigen levels. According to Pfizer, the manufacturer of the drug, and notably, this marks the first approval of an androgen receptor signaling inhibitor that is FDA approved for this patient population.
The approval is based on findings from the randomized phase 3 EMBARK clinical trial were five-year metastasis free survival, which is the time from treatment until metastatic disease was 87.3% in the Xtandi arm, compared with 71.4% and the leuprolide-only group and 80% in the monotherapy group, according to findings that were published in the New England Journal of Medicine.
Drug Shortages Continue to Be a ‘Serious Problem’ in Oncology
While the shortage of the chemotherapy drugs, cisplatin and carboplatin, seems to be improving, drug shortages, in general, are not a new problem and likely are not going anywhere soon, according to Corey McEwen, the director of oncology pharmacy services at Massachusetts General Hospital in Bostin.
McEwen explained that most of these drugs are manufactured outside of the United States. The FDA will approve certain locations to make the drugs, which then are shipped to the wholesaler, then the cancer treatment center or clinic and finally, to the patients. However, at no point during that process is there an obligation to be transparent about drugs that are in shortage or at risk to be in shortage.
Additionally, with increased demand and decreased supply, the price of these therapies can go up. At Mass. General, McEwen said that the institution will oftentimes take on the financial burden of the increased cost, because they are mainly focused on getting the drugs in the first place. However, that may not be the case in all cancer treatment centers, leading to more disparities and financial burdens from cancer care.
Diabetes Severity Associated With Poor Colorectal Cancer Survival
Research published in the journal, Cancer, analyzed outcomes for patients with diabetes and colorectal cancer who underwent surgery for their cancer. Findings showed that patients with more severe diabetes tended to have poorer survival outcomes. This was particularly the case for patients who were female or in their earlier stages of cancer.
The researchers theorized that the relationship between diabetic severity and cancer prognosis may be explained by three mechanisms:
- Diabetes can lead to increased levels of insulin-like growth, which can accelerate tumor growth
- High blood sugar levels may result in poor response to chemotherapy
- The potential increased accumulation of genetic mutations that result from the high inflammatory burden caused by diabetes
Vitamin D May Help Prevent Chemo-Induced Neuropathy
Once again, vitamin D made oncology headlines last week. This time, findings published in the Journal of the National Comprehensive Cancer Network found that patients who were deficient in vitamin D before starting treatment with paclitaxel had higher rates of chemotherapy-induced peripheral neuropathy than patients with sufficient vitamin D levels.
Peripheral neuropathy is a common side effect from certain types of chemotherapy drugs that presents as numbness, tingling or a stabbing feeling in the hands and/or feet. Eventually if the neuropathy gets so bad, patients can have a higher risk of falls or become unable to perform some essential everyday tasks, such as preparing food or getting dressed. There is currently no cure for the condition, so potential prevention or mitigation strategies — like getting enough vitamin D — are particularly important.
I spoke with study author Dr. Dan Hertz who said that while more research is needed in this space, it is worth it for patients to check their vitamin D levels and take a supplement, if needed.
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