Latest Healthcare News and Research Updates

CAR T-cell Therapies to include Second Malignancies in Labeling: European Medicines Agency

The European Medicines Agency (EMA) will follow the US FDA’s lead and require a warning label for Car T-cell therapies to highlight the risk of second malignancies. The therapy is used to treat aggressively growing cancers, but it also involves genetic engineering of the patient’s immune cells. While it was shown to be effective in treating cancer, it is also associated with a risk of developing secondary cancer. Therefore, EMA mandates that patients who have received or are eligible for Car T-cell therapy should be monitored for life.

Supreme Court to Hear Lawsuit Against Medicare

A group of more than 200 hospitals has filed a lawsuit in the Supreme Court against Medicare, alleging that the organization underpaid facilities that serve low-income populations. Hospitals that serve such populations are typically reimbursed at a lower rate than other health care providers. The hospitals claim that this results in lower-quality care that they are unable to provide because of inadequate funding. The Supreme Court has agreed to hear arguments in the case.

AstraZeneca’s Breast Cancer Drug Fails Phase III Trial

AstraZeneca announced that its breast cancer treatment drug capivasertib (Truqap) failed to improve overall survival in a phase III trial. The trial involved patients diagnosed with an aggressive form of breast cancer. Patients who received capivasertib along with paclitaxel did not have better survival outcomes than those who were treated with paclitaxel and placebo drugs. It was a significant setback for AstraZeneca as capivasertib was one of the key therapy candidates in its pipeline.

Amgen’s Drug Gets New Indications

The US FDA expanded the indications for Amgen’s blinatumomab (Blincyto) to include treatment of B-cell precursor acute lymphoblastic leukemia in children and adults. The drug is a bispecific T cell engager that can help the immune system fight cancer cells. It is already approved for a type of cancer that affects bone marrow and the blood and has shown promising outcomes in clinical trials.

Partial Hold Placed on Clinical Study for BioNTech Drug

The US FDA has placed a partial hold on an early-stage clinical study of BioNTech’s antibody-drug conjugate (ADC) being tested on patients with previous lung and breast cancer treatment due to an unsatisfactory risk of injury or illness at higher doses. The ADC works by delivering an antibody to cancer cells while simultaneously dispensing a toxin that destroys cancer cells. Such concerns being highlighted can cause further delays to the development of the drug and increase costs of the trial.

Clinical Studies for WEE1 Inhibitor Azenosertib Placed on Hold After Patient Deaths

Zentalis Pharmaceuticals has announced that the FDA placed a hold on three clinical trials of the WEE1 inhibitor azenosertib, following two deaths caused by suspected sepsis in the trial. The drug works by stopping the growth of tumor cells and makes them more sensitive to chemotherapy. The clinical hold would result in limiting the number of patients participating in clinical trials for the drug, thereby delaying the development process.

Celecoxib Shows Improvement in Colon Cancer Survival

Patients who received the anti-inflammatory drug celecoxib after surgery for colon cancer showed better overall survival and disease-free survival in a recent study. In the study, patients with a specific genetic mutation were given the drug celecoxib, which is commonly used for arthritis pain relief, in the year after surgery. As per the results, the drug reduced the risk of colon cancer recurrence by as much as 30 percent.

Serial Measurement of Immunoglobulin G Helps Lower the Rate of Infection

Patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma had a significantly lower rate of infection when their immunoglobulin G was measured serially. Immunoglobulin G is an essential antibody that plays a critical role in a person’s immunity and natural defense against pathogens. Patients with chronic lymphocytic leukemia and non-Hodgkin’s lymphoma are particularly prone to infections.

Investigational Leukocyte Interleukin Injection Improves Head and Neck Cancer Survival

An investigational injection called Multikine has been shown to improve survival for patients with head and neck cancer who have low levels of PD-L1 expression. Multikine is an interleukin-based drug that boosts the immune system in the treatment of cancer. The patients were given the drug before surgery, and the results showed lower mortality rates and better disease control.

Neoadjuvant and Adjuvant Chemotherapy Improves Survival in Pancreatic Cancer

Patients who underwent neoadjuvant chemotherapy for pancreatic cancer showed an improved prognosis in a study that compared neoadjuvant and adjuvant chemotherapy with adjuvant therapy only. Neoadjuvant chemotherapy is used to shrink tumors so that they can be surgically removed. Patients who underwent neoadjuvant and adjuvant chemotherapy had better outcomes than those who opted for adjuvant therapy only.

Conclusion

Healthcare and medicine are evolving rapidly with new treatments, drugs, and research findings regularly in the news. While the new therapies and treatments show promise in treating the diseases, some have not yet met the expectations set out in clinical studies. The continuous evolution of healthcare requires regulatory bodies to ensure the safety of patients and promote evidence-based treatments for the best possible outcomes. It is important to note that any healthcare-related decision should be taken in consultation with your healthcare provider.

Originally Post From https://www.medpagetoday.com/hematologyoncology/othercancers/110766

EU Updates Warning on CAR-T and Announces New Blincyto Treatment for Pancreatic Cancer