Αρχική World News 2021 ASCO Annual Meeting: New Treatments and Research Advances in Esophageal Cancer,...

2021 ASCO Annual Meeting: New Treatments and Research Advances in Esophageal Cancer, Prostate Cancer, Breast Cancer, Cervical Cancer, Kidney Cancer, and Nasopharyngeal Cancer

Tomorrow, the 2021 ASCO Annual Meeting will begin virtually. Thousands of oncology professionals and allied members of the cancer care community from around the world will gather online to learn about the latest research in the treatment and care of people with cancer. Learn more about some of the research that will be presented at this meeting.

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Some of the notable research that will be presented at the meeting includes: 

Immunotherapy combinations for advanced esophageal cancer help people live longer

Who does this study affect: People with advanced esophageal squamous cell carcinoma who have not yet received treatment. 

What did this study find: The phase 3 CheckMate 648 study found that combining nivolumab (Opdivo) with either ipilimumab (Yervoy) or with a chemotherapy regimen using 5-fluorouracil (5-FU) and cisplatin (available as a generic drug) as a first-line treatment for advanced esophageal squamous cell carcinoma helps patients live longer. Patients with tumors that expressed the PD-L1 protein saw the best results, but the treatment also worked on some tumors that did not express PD-L1.  

Esophageal squamous cell carcinoma (ESCC) is the most common type of esophageal cancer globally, and advanced ESCC that has spread is difficult to treat. The 5-year survival rate for esophageal cancer that has spread to distant parts of the body is 5%. Currently, the standard first-line treatment for people with advanced ESCC that cannot be treated with surgery is chemotherapy. Globally, the median survival time for people treated this way is 10 months. The median is the midpoint, meaning that half of the participants in this group lived longer than 10 months, and the other half lived less than that.

In this study, researchers looked at 2 different immunotherapy drugs, nivolumab and ipilimumab. Nivolumab is a checkpoint inhibitor that blocks the PD-L1 protein. PD-L1 is a protein that cancer cells use to hide from the immune system. Ipilimumab blocks another protein that stops the immune system from attacking cancer cells, called the CTLA-4 protein. The study tested 3 different treatment approaches: combining nivolumab and the chemotherapy regimen, combining nivolumab and ipilimumab, and giving the chemotherapy regimen alone. In the groups that received immunotherapy, the study participants could receive treatment for up to 2 years or until the cancer showed signs of growing and spreading or side effects caused the patient to stop receiving treatment. The goal of the study was to see if these new combinations with immunotherapy could extend survival for people with advanced ESCC, compared to the current approach of using chemotherapy alone.

This study included 970 participants with advanced ESCC from around the world, and just under half of them had tumors that expressed the PD-L1 protein. The participants were randomly assigned to 1 of the 3 groups:  nivolumab and ipilimumab, nivolumab and chemotherapy, or chemotherapy alone, which is the current standard of care. The results show that both of the new immunotherapy combinations improved overall survival for all patients, compared with chemotherapy alone.

Patients with a tumor with PD-L1 expression experienced better results when immunotherapy was used. Patients with a tumor with PD-L1 expression who received nivolumab and chemotherapy lived for a median of 15.4 months. The patients who received nivolumab and ipilimumab lived for a median of 13.7 months, and those who received chemotherapy alone lived for a median of 9.1 months.

Both new treatment combinations helped people live longer, regardless of whether the tumor expressed PD-L1. Across all patients who received nivolumab and chemotherapy, the median overall survival was 13.2 months, and patients who received nivolumab and ipilimumab had an overall survival of 12.8 months. In comparison, those receiving chemotherapy alone had a median overall survival of 10.7 months. The rate of side effects was similar between all treatments, but people who received nivolumab and chemotherapy were more likely to stop treatment because of severe side effects.

What does this mean for patients: For people with advanced ESCC, first-line treatment with nivolumab and chemotherapy or nivolumab and ipilimumab may provide alternatives to chemotherapy alone that can help people live longer. For people with a tumor that expresses PD-L1, nivolumab plus chemotherapy offered the best results, but it also had the highest rate of side effects.

“The clinically meaningful improvements in survival of these 2 treatment regimens highlight immunotherapy’s impact on cancer care and should bring new therapeutic options to a group of patients that are often diagnosed when disease has already spread.”

— lead study author Ian Chau, MD, FRCP
Royal Marsden Hospital
 Sutton, United Kingdom

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New targeted radiation treatment effective against metastatic castration-resistant prostate cancer

Who does this study affect: People with metastatic castration-resistant prostate cancer (mCRPC) that has not been stopped by treatment with androgen inhibitors and taxane chemotherapy.

What did this study find: The phase 3 VISION clinical trial has shown that a targeted radiation treatment called lutetium-177-PSMA-617 (177Lu-PSMA-617 or LuPSMA) added to current standard treatments slows the progression of mCRPC for about 5 months longer than the current standard of care and helps people live about 4 months longer than the current standard of care.

When the growth of advanced prostate cancer is no longer slowed by low testosterone levels in the body and the cancer has spread to other parts of the body, it is called mCRPC. There is no cure for mCRPC, and it can be difficult to treat. Currently, ASCO recommends treatment that continues to lower hormone levels in the body as well as androgen inhibitors, such as abiraterone acetate (Zytiga) or enzalutamide (Xtandi), and chemotherapy with docetaxel (Taxotere), as well as other treatments.

About 80% of people with prostate cancer have cancer cells that express a protein called PSMA (prostate-specific membrane antigen) at increased levels, including those with metastatic disease. PSMA is already used as a target for a type of PET-CT scan, called gallium-68 PSMA-11, to find whether prostate cancer has spread to other parts of the body. The treatment being studied in this clinical trial finds PSMA on the surface of prostate cancer cells and delivers a dose of radiation directly to the cell and a very small area around it. Broader terms for this type of targeted radiotherapy approach are radioligand therapy (RLT) and peptide receptor radionuclide therapy (PRRT). 177Lu-PSMA-617 is given by infusion into a vein.

This study included 831 participants with mCRPC who were recruited from June 2018 to October 2019. They had all received treatments with androgen inhibitors and 1 or 2 chemotherapy regimens. There were 551 people assigned to the group that received 177Lu-PSMA-617 plus standard-of-care treatments. The remaining 280 participants were assigned to the control group, which received standard-of-care treatments only. As described above, there are no clear choices about the best standard of care if androgen inhibitors and chemotherapy are no longer effective at stopping mCRPC. 

After a median follow-up of nearly 21 months, the researchers saw that the cancer was stopped for a median of 8.7 months in the 177Lu-PSMA-617 group, compared with a median of 3.4 months in the control group. In terms of overall survival, people in the 177Lu-PSMA-617 group lived for a median of 15.3 months, compared with a median of 11.3 months in the control group. 

Bone problems may be caused or worsened by any hormonal therapy for prostate cancer, or the cancer itself may spread to the bone. In this study, treatment with 177Lu-PSMA-617 delayed bone problems that caused symptoms to 11.5 months, compared with 6.8 months in the control group. Serious side effects were more common in the 177Lu-PSMA-617 group (52.7% of patients) compared with the control group (38% of patients). The most common, low-grade side effects of 177Lu-PSMA-617 were fatigue, dry mouth, nausea, anemia, and back pain.

What does this mean for patients: Treatment with 177Lu-PSMA-617 may provide a new option for people with mCRPC that has not been stopped by existing standard-of-care treatments.

“The findings suggest that 177Lu-PSMA-617 warrants consideration as a new standard of care in this patient population, pending regulatory review and approval.”

—lead study author Michael J. Morris, MD
Memorial Sloan Kettering Cancer Center
New York, New York 

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Olaparib reduces risk of recurrence and metastasis in people with a BRCA mutation and early-stage, HER2-negative breast cancer

Who does this study affect: People with an inherited BRCA1 or BRCA2 gene mutation and early-stage, HER2-negative breast cancer with a high risk of coming back, called recurrence.

What did this study find: Results from the phase 3 OlympiA clinical trial showed that 1 year of adjuvant olaparib (Lynparza) can significantly reduce the risk of recurrence and prevent metastasis in people with high-risk, early-stage, HER2-negative breast cancer who have an inherited BRCA1 or BRCA2 gene mutation. Adjuvant treatment is the therapy given after the main treatment. Metastasis is cancer that has spread to another part of the body.

Olaparib is a type of targeted therapy called a PARP inhibitor. PARPs are enzymes that repair damaged DNA. The BRCA genes (BRCA1 and BRCA2) are also normally involved in DNA repair, but having a mutation, or change, in these genes interferes with their ability to repair DNA. When BRCA genes are no longer able to repair DNA, PARPs take over this responsibility. By making repairs to DNA, PARPs allow cancer cells to continue growing and dividing. PARP inhibitors like olaparib work by blocking PARP enzymes from repairing DNA. When PARPs are blocked, the DNA inside cancer cells is less likely to be repaired, which can destroy the cancer cell and slow or stop a tumor’s growth. Olaparib is currently approved for people with metastatic HER2-negative breast cancer and a BRCA1 or BRCA2 gene mutation as an alternative to chemotherapy.

Up to 10% of all breast cancers are in people with an inherited BRCA1 or BRCA2 mutation. Even when people with high-risk, early-stage breast cancer and a BRCA1 or BRCA2 mutation receive chemotherapy before or after surgery, their risk for recurrence can still be high. Because of this, more aggressive adjuvant treatment may be recommended.

The 1,836 participants in the OlympiA study had high-risk, early-stage, HER2-negative breast cancer that was either triple-negative or hormone-receptor-positive and had a BRCA1 or BRCA2 mutation. People in the study had all received chemotherapy either before or after their main treatment of surgery, as well as radiation therapy, if necessary. They were then randomly assigned to receive either olaparib (921 participants) or standard treatment plus a placebo (915 participants) for 1 year. (Learn more about placebos in cancer clinical trials.)

After a median of 2.5 years of follow-up, the researchers found that olaparib significantly reduced the chance of recurrence. They estimated that by 3 years, 85.9% of those receiving olaparib would be free of invasive disease, compared with 77.1% of those receiving the placebo. Furthermore, the chance of the cancer spreading to another part of the body was also improved with olaparib. Of those receiving olaparib, an estimated 87.5% would be free of metastatic disease, compared with 80.4% of those who received the placebo.

The most common side effects of olaparib were a low level of red blood cells (anemia), a low level of white blood cells (neutropenia and leukopenia), fatigue, and a low level of lymphocytes in the blood (lymphocytopenia). In general, the rate of serious side effects was the same between both study groups.

What does this mean for patients: For people with a BRCA1 or BRCA2 mutation and high-risk, early-stage, HER2-negative breast cancer, adjuvant olaparib may help lower the risk of recurrence and prevent the cancer from spreading to other parts of the body.

“The OlympiA study results, the first reporting the effects of a PARP inhibitor as an ‘adjuvant therapy’ on survival endpoints, suggest a possible addition to the standard of care for patients with germline BRCA1/2 mutation-associated early breast cancer who have levels of recurrence risk requiring neoadjuvant or adjuvant chemotherapy.”

—lead study author Professor Andrew Tutt, MB ChB, PhD, FMedSci
Institute of Cancer Research and Guy’s Hospital King’s College London
London, United Kingdom

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More chemotherapy does not help people with locally advanced cervical cancer live longer

Who does this study affect: People with locally advanced cervical cancer.

What did this study find: The phase 3 OUTBACK clinical trial found that adjuvant chemotherapy given after treatment with chemoradiation did not help people with locally advanced cervical cancer live longer. Treatment given after the main treatment is called adjuvant treatment.

Locally advanced cervical cancer means it has spread beyond the cervix but not to other parts of the body. The main standard treatment option for locally advanced cervical cancer is chemoradiation. Chemoradiation is a combination of chemotherapy and radiation therapy. It can be used alone or combined with surgery to treat the cancer. However, about 1 out of every 3 people who receive chemoradiation still experiences a recurrence, which is when the cancer has come back. Recurrent cervical cancer can spread to other parts of the body, called metastasis, and this can be life-threatening. For this reason, many people with cervical cancer have been given more chemotherapy after standard chemoradiation in an effort to lower the risk of recurrence.

The OUTBACK clinical trial evaluated whether giving adjuvant chemotherapy after chemoradiation in people with locally advanced cervical cancer helped them live longer. This international study included 919 participants who had stage IB1, IB2, II, IIIB, or IVA cervical cancer. Participants were randomly assigned to 2 groups, either receiving standard chemoradiation alone using cisplatin (available as a generic drug) or receiving chemoradiation with adjuvant chemotherapy using 4 cycles of carboplatin (available as a generic drug) and paclitaxel (Taxol).

The researchers found that adjuvant chemotherapy after chemoradiation did not help people live longer. After 5 years, 72% of those receiving adjuvant chemotherapy were still alive, compared with 71% of those receiving chemoradiation alone. Additionally, rates of cancer recurrence were similar for both groups. Among those receiving adjuvant chemotherapy, 63% did not have a cancer recurrence, compared with 61% of those receiving chemoradiation alone. And, serious side effects were more common with adjuvant chemotherapy, including peripheral neuropathy. By 1 year, 81% of participants receiving adjuvant chemotherapy had experienced a serious side effect, compared with 62% of those receiving chemoradiation alone.

What does this mean for patients: More chemotherapy after standard chemoradiation for locally advanced cervical cancer does not help people live longer and can lower patients’ quality of life.

“The study confirms that chemoradiotherapy alone is currently our best possible treatment for women with locally advanced cervical cancer. Not only is there no benefit with adjuvant chemotherapy, but severe side effects are also increased.”

 —lead study author Linda R. Mileshkin, MD
 Peter MacCallum Cancer Centre
Melbourne, Australia

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Pembrolizumab given after surgery reduces risk of kidney cancer recurrence

Who does this study affect: People with clear cell kidney cancer that has a higher chance of coming back after surgery.

What did this study find: An early analysis of the data in the phase 3 KEYNOTE-564 clinical trial shows that pembrolizumab (Keytruda) given after surgery may lower the risk of recurrence for clear cell renal cell carcinoma (RCC).

Clear cell RCC is the most common type of kidney cancer. Clear cell RCC accounts for about 70% of all kidney cancers. For many people, the first treatment for RCC is surgery to remove part or all of the affected kidney, which is called a partial or radical nephrectomy. However, for up to 40% of people with RCC, the cancer will come back, or recur, after surgery and often the recurrent disease will have spread to other parts of the body, which is called metastasis. To prevent the kidney cancer from coming back, many people are offered adjuvant treatment, which is a treatment given after surgery to destroy any remaining cancer cells that are in the body but undetectable. The adjuvant treatments currently available for kidney cancer include radiation therapy, chemotherapy, and targeted therapy, but they are not always effective.

In this study, the researchers used the immune checkpoint inhibitor pembrolizumab (Keytruda) as adjuvant treatment after nephrectomy. Pembrolizumab is a type of immunotherapy that targets the PD-1 protein in an effort to boost the body’s natural defenses to fight cancer. Currently, pembrolizumab is approved for use in a combination with axitinib (Inlyta, a type of targeted therapy) as a first treatment for advanced RCC. 

This study included 994 people with clear cell RCC who were in general good health and had received surgery to remove all the visible tumor in the past 12 weeks but had not received any adjuvant therapy using medication. Participants had an intermediate or high risk of having the cancer come back based on several factors, including tumor size, how different the cancer cells looked from healthy cells under a microscope, and whether the cancer had spread to the lymph nodes or other regions of soft tissue. Among these participants, 496 were assigned to the group to receive adjuvant pembrolizumab for 1 year and 498 were assigned to receive a placebo. (Learn more about placebos in cancer clinical trials.)

At the time of this data analysis, the study participants had been followed for a median of 24.1 months. The median is the midpoint, meaning that half of the people had been followed for more than 24.1 months and the other half had been followed for less than 24.1 months. The researchers found that treatment with pembrolizumab led to a 32% lower risk of recurrence and death. Because this clinical trial is still running, the researchers only had enough data to estimate the disease-free survival at 2 years for both study groups. For this study, disease-free survival was defined as the length of time until the kidney cancer came back, the cancer spread to a distant part of the body, or the patient died for any reason. At 2 years, the researchers estimated that 77.3% of the participants who received pembrolizumab would be alive and without recurrent cancer, compared with 68.1% of those who received the placebo.

Serious side effects were more common among those who received pembrolizumab (32.4%) than in those who received the placebo (17.7%).

What does this mean for patients: There are few adjuvant treatment options that are currently used for people with clear cell RCC with an increased risk of recurrence. The first analysis of the data from this clinical trial shows that the immunotherapy drug pembrolizumab may be helpful at preventing recurrence after surgery.

“Pembrolizumab may provide a promising treatment for patients for whom there are few therapy options. KEYNOTE-564’s disease-free survival supports pembrolizumab as a potential new standard of care in the adjuvant setting to delay disease recurrence for patients with fully resected clear cell RCC.”

—lead study author Tony Choueiri, MD
Dana Farber Cancer Institute
Boston, Massachusetts

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Adding toripalimab to chemotherapy slows the growth of recurrent or metastatic nasopharyngeal cancer

Who does this study affect: People with recurrent or metastatic nasopharyngeal carcinoma.

What did this study find: The JUPITER-02 phase 3 clinical trial found that adding the immunotherapy drug toripalimab to standard first-line chemotherapy lengthened progression-free survival time for people with recurrent or metastatic nasopharyngeal carcinoma. Progression-free survival is the amount of time before cancer grows or spreads to other parts of the body.

Nasopharyngeal carcinoma affects the nasopharynx, which is the air passage between the nose and the throat and lungs. While uncommon in the United States, this head and neck cancer is much more common in other regions of the world, including East Asia and Southeast Asia. Currently, the standard of care for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma is a chemotherapy regimen using gemcitabine (Gemzar) and cisplatin (available as a generic drug). However, this treatment tends to work for about 6 to 7 months on average based on previous studies. Researchers are looking for new treatments that can help people with nasopharyngeal carcinoma live longer.

This study compared the current standard chemotherapy plus a placebo with a combination of the immunotherapy drug toripalimab and chemotherapy. The 289 participants in this study had recurrent or metastatic nasopharyngeal cancer that had not been treated with chemotherapy. Participants were randomly divided into 2 groups. One group received the standard chemotherapy treatment of gemcitabine and cisplatin plus a placebo. (Learn more about placebos in cancer clinical trials.) The other group received the same chemotherapy, gemcitabine and cisplatin, plus toripalimab.

Toripalimab targets the PD-1 protein expressed on immune cells. PD-1 interacts with a protein called PD-L1. PD-L1 helps cancer cells avoid the immune system, which allows them to grow. Elevated PD-L1 expression is often found in nasopharyngeal carcinomas. By blocking this interaction between the PD-1 and PD-L1 proteins, toripalimab boosts the immune system’s ability to fight the cancer.

Participants in the group that received the toripalimab combination had longer progression-free survival compared with those who received standard treatment. The median progression-free survival was 11.7 months with the toripalimab combination, and, at 1 year, the cancer had not grown or spread in 49% of patients. The median progression-free survival was 8 months with the standard chemotherapy, and, at 1 year, the cancer had not grown or spread in 28% of patients.

The rates of side effects were similar for both groups, with about 89% of patients in each group experiencing a serious side effect. Side effects caused 7.5% of people to stop treatment with the toripalimab combination and 4.9% of people to stop treatment with the standard chemotherapy. Those who received the toripalimab combination experienced more immune system-related side effects (39.7%) than those who received standard chemotherapy (18.9%). Serious immune-related side effects were also more common with immunotherapy treatment (7.5%) than with standard chemotherapy (0.7%). The most common immune-related side effects in this study were reduced thyroid functioning (17.8% vs 8.4%), itchy skin (6.2% vs 3.5%), rash (8.9% vs 4.2%), elevated levels of the liver function markers AST (4.8% vs 1.4%) and ALT (4.1% vs 1.4%) in the blood, and an elevated blood thyroid stimulating hormone level (4.1% vs 2.1%).

What does this mean for patients: Adding toripalimab to standard first-line chemotherapy may help slow the growth of recurrent or metastatic nasopharyngeal carcinoma.

“Nasopharyngeal carcinoma is challenging as it is typically diagnosed in an advanced stage when current therapy options are extremely limited. The extended response in patients who received toripalimab marks a significant advance for treatment of this disease.”

—lead study author Rui-hua Xu, MD, PhD
Sun Yat-sen University Cancer Center
Guangzhou, China

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Stay Informed

Visit the Cancer.Net Blog for more reports about the 2021 ASCO Annual Meeting program. You can also keep up with the news from the program by following Cancer.Net on Facebook and Twitter. Follow the  #ASCO21 hashtag on Twitter to learn more about research from this meeting.

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