FDA Grants Bevacizumab Priority Review for Recurrent Platinum-Resistant Ovarian Cancer

The gist: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process.The drug Avastin (bevacizumab), already FDA-approved for several subtypes of several different cancers, was recently granted Priority Review status for the treatment of women with recurrent platinum-resistant ovarian cancer. The decision was based on promising results for the treatment in a clinical trial with volunteer patients.

“The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.

“ ‘The majority of women with ovarian cancer will become resistant to platinum therapy, and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.

“The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide ‘significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.’ The supplemental Biologics License Application for bevacizumab plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the phase III AURELIA trial.”


FDA Grants Genentech’s Avastin Priority Review for Certain Types of Cervical Cancer

“Genentech, a member of the Roche Group (six:RO)(six:ROG)(otcqx:RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin® (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastaticcervical [sic] cancer.

“ ‘This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients.’ ”

“The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide ‘significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.’ The sBLA for Avastin plus chemotherapy in persistent, recurrent or metastaticcervical cancer is based on data from the Phase III GOG-0240 trial with an FDA action date of October 24, 2014.”

The gist: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process. The drug Avastin (bevacizumab), already FDA-approved for several subtypes of several different cancers, was recently granted Priority Review status for the treatment of women with persistent, recurrent or metastatic cervical cancer. These patients currently only have the option of being treated with chemotherapy, but clinical trial evidence indicates that adding Avastin to the standard chemotherapy regimen might help these women live longer.


Cetuximab or Bevacizumab with Combi Chemo Equivalent in KRAS Wild-Type MCRC

“For patients with KRAS wild-type untreated colorectal cancer, adding cetuximab or bevacizumab to combination chemotherapy offers equivalent survival, researchers said at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.” ‘The CALGB/SWOG 80405 trial was designed and formulated in 2005, and the rationale was simple: we had new drugs —bevacizumab and cetuximab— and the study was designed to determine if one was better than the other in first-line for patients with colon cancer,’ said lead study author Alan P. Venook, distinguished Professor of Medical Oncology and Translational Research at the University of California, San Francisco, USA.

“The CALGB/SWOG 80405 trial studied patients whose tumours were KRAS wild-type at codons 12 and 13. Patients received mFOLFOX6 or FOLFIRI at the discretion of their doctor and were randomised to cetuximab (578 patients) or bevacizumab (559 patients).

” ‘There was no meaningful difference in outcome between treatment arms,’ said Venook. ‘In both arms patients lived close to 30 months. About 10% of patients lived more than 5 years. Overall patients did much better than anticipated and it was indifferent to the type of treatment.’ ”

Editor’s note: This story discusses the results of a clinical trial that tested a treatment for colorectal cancer in volunteer patients without mutations in the KRAS gene in their tumors (as detected by molecular testing). The goal of the trial was to compare two chemotherapy drugs—bevacizumab and cetuximab—to see whether one is better than the other as a first-line colorectal cancer for so-called “KRAS wild-type” colorectal cancer. The results showed that there was no significant difference between the two.


General Oncology – Six-Gene Signature Predicts Survival After Targeted Therapy for NSCLC

“The presence of a six-gene profile in the microRNA of patients with advanced non-squamous non-small-cell lung cancer (NSCLC) predicts reduced survival likelihood after first-line treatment with targeted therapy followed by chemotherapy for disease progression, indicate research results.

“While the findings ‘should be further validated’, the researchers believe their analysis ‘supports the hypothesis that circulating [microRNA’s] may further be developed as predictive markers for EGFR-targeted treatment’ in an NSCLC population whose response to epidermal growth-factor receptor (EGFR) tyrosine kinase inhibitors is unknown.”

Editor’s note: This story describes a new, blood test-based method by which oncologists may be able to predict the effects of targeted therapy treatment on the survival of patients with non-squamous non-small cell lung cancer (NSCLC). Specifically, it may be able to predict the effects of first-line treatment with drugs known as EGFR inhibitors, which are prescribed to people whose tumors have mutations in the EGFR gene, as detected by molecular testing. In a study with volunteer patients, scientists took blood samples just before and just after the patients began taking the drugs bevacizumab or erlotinib. The scientists identified six different kinds of a molecule called microRNA that, if present, were associated with a lower chance of survival (29 months versus more than 45 months). More testing will be needed to determine if this six-gene signature can be used widely; it would be a non-invasive alternative to making predictions and monitoring treatment effectiveness using repeat tumor biopsies.


ASCO: Targeted Tx Combo Stalls NSCLC

“Adding bevacizumab (Avastin) to first-line targeted therapy delayed progression in a subgroup of non-small cell lung cancer (NSCLC), an open-label trial showed.

“Progression-free survival was 46% better with bevacizumab plus erlotinib (Tarceva), at 16.0 months compared with 9.7 on erlotinib alone in an EGFR mutation-positive population (P=0.0015), Terufumi Kato, MD, of Kanagawa Cardiovascular and Respiratory Center in Yokohama, Japan, and colleagues found.”

Editor’s note: A combination of two targeted therapy drugs has shown promise for treating some patients with non-small cell lung cancer (NSCLC). The two drugs are called bevacizumab (brand name Avastin) and erlotinib (brand name Tarceva). The research described in this story found that the combination works better for patients whose tumors have mutations in the EGFR gene (as detected by molecular testing) than erlotinib alone.


10 Issues to Consider During National Skin Cancer Awareness Month

“Accounting for approximately half of all cancers in the United States, skin cancer is widely recognized as the most common cause of cancer nationwide. More than 3.5 million cases of skin cancer are diagnosed each year, and according to the Skin Cancer Foundation, incidences of skin cancer outnumber all combined cases of breast, colon, lung and prostate cancers.

“With the month of May designated as National Skin Cancer Awareness Month, HemOnc Today highlights 10 issues for oncologists and dermatologists to consider for their patients, as well as the new guideline revisions and research regarding the identification, treatment and management of patients with melanoma and skin cancer.”


ELCC 2014 News: Efficacy and Safety of Targeted Therapy in Elderly Patients With Lung Cancer Adenocarcinoma

“Clinical records of elderly patients with non-small-cell lung cancer (NSCLC) show that treatment with bevacizumab seems to be safe and effective in patients with controlled pre-existing cardiovascular disease and good performance status. Furthermore, another targeted agent, erlotinib, represents a valuable treatment option in elderly NSCLC patients with co-morbidities, especially if they harbour EGFR mutations. The data were presented by Prof. Kostas Syrigos on behalf of colleagues from the Oncology Unit, Sotiria General Hospital, Athens School of Medicine, Athens, Greece in a general poster session at the 4th European Lung Cancer Conference (26-29 March 2014, Geneva, Switzerland).”


Hint of Survival Benefit with Bevacizumab-Pemetrexed Maintenance for NSCLC

“Updated data from the phase III AVAPERL trial hint that there might be an overall survival (OS) benefit of using bevacizumab in combination with pemetrexed as maintenance therapy in patients with advanced nonsmall cell lung cancer (NSCLC).

“ ‘The AVAPERL study was not powered to detect differences in OS between treatment arms’, Fabrice Barlesi, of Aix Marseille University in France, and colleagues observe in the Annals of Oncology.

“ ‘The analysis revealed, however, that OS was numerically increased by nearly 4 months in patients treated with maintenance bevacizumab-pemetrexed as compared with bevacizumab alone’, the international team of researchers reports.”

Editor’s Note: Maintenance therapy is “treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy. It may include treatment with drugs, vaccines, or antibodies that kill cancer cells, and it may be given for a long time,” according to the National Cancer Institute. Patients in this study were found to have longer survival times when taking a combination of the drugs bevacizumab and pemetrexed as a maintenance therapy than when taking bevacizumab alone.


Lung Cancer Drug BGB324 May Counteract Drug Resistance

The protein Axl has been associated with cell transformation processes that contribute to the spread of cancer through the body and to cancers becoming drug resistant. A recent study investigated the effect of the Axl inhibitor BGB324 on non-small cell lung cancer (NSCLC) cells that had become resistant to EGFR inhibitors like erlotinib (Tarceva). BGB324 restored the effectiveness of EGFR inhibitors against these cancer cells, which had been grown either in a matrix or as tumors in mice. BGB324 also appeared to enhance the effectiveness of the chemotherapy drug docetaxel (Taxotere) and of bevacizumab (Avastin). BGB324 may therefore be a promising new candidate for treating drug-resistant NSCLC. The drug will be tested in a phase Ib clinical trial for NSCLC in 2014.