Lilly Receives FDA Breakthrough Therapy Designation for Abemaciclib – a CDK 4 and 6 Inhibitor – in Advanced Breast Cancer

“Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer. This designation is based on data from the breast cancer cohort expansion of the company’s Phase I trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. Patients in this cohort had received a median of seven prior systemic treatments. These data were presented at the San Antonio Breast Cancer Symposium in 2014.”


Nivolumab/Ipilimumab Combination FDA Approved for BRAF Wild-Type Melanoma

“The combination of nivolumab and ipilimumab has received accelerated FDA approval as a treatment for patients with BRAF V600 wild-type (WT) unresectable or metastatic melanoma, based on findings from the phase II CheckMate-069 study.

” ‘Historically, metastatic melanoma has been a difficult disease to treat. Now, a new treatment option based on the combination of two valued immuno-oncology agents demonstrates significant efficacy versus ipilimumab in metastatic melanoma,’ said Jedd D. Wolchok, MD, PhD, chief, Melanoma and Immunotherapeutics Service, Department of Medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center, in a statement. ‘Today’s approval represents a step forward for the melanoma community, providing hope for patients with metastatic melanoma.’ ”


FDA Grants Alectinib Priority Review in NSCLC

“Alectinib has received an FDA priority review designation for patients with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib (Xalkori), according to Genentech, the manufacturer of the oral second-generation ALK inhibitor. The FDA’s action date for an approval decision is March 4, 2016.

“The priority review is based on two phase II trials (NP286731and NP287612) which demonstrated that alectinib had robust activity in patients with ALK-positive NSCLC following progression on crizotinib (Xalkori), including individuals with CNS metastases.

“ ‘Alectinib was granted priority review by the FDA based on results from two studies showing the medicine shrank tumors in people with ALK-positive NSCLC that progressed on crizotinib,’ Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a statement. ‘There is a need for new treatment options in this patient population, especially because the disease often spreads to the brain at progression.’ “


FDA Grants Nivolumab Priority Review in Nonsquamous NSCLC

“Nivolumab (Opdivo) has received an FDA priority review designation for patients with previously treated nonsquamous non­–small cell lung cancer (NSCLC), according to the developer of the PD-1 inhibitor, Bristol-Myers Squibb (BMS). Under the expedited process, the FDA’s decision deadline is January 2, 2016.

“The FDA simultaneously granted nivolumab a breakthrough therapy designation in this setting. The priority and breakthrough designations are based on data from the phase III CheckMate-057 trial, in which second-line nivolumab reduced the risk of death by 27% versus docetaxel in patients with nonsquamous NSCLC, including a 60% risk reduction among patients with the highest levels of PD-L1 expression.

“Nivolumab was previously approved in March 2015 for patients with squamous cell NSCLC who have progressed on or after platinum-based chemotherapy.”


FDA Grants Orphan Drug Designation to MTG-201 for Malignant Mesothelioma

“The FDA granted orphan drug designation to MTG-201 for the treatment of patients with malignant mesothelioma, according to a press release.

“MTG-201 (MTG Biotherapeutics) is an advanced biologic therapy that targets Dickkopf-3 gene defects in various cancer types. The Dickkopf-3 gene produces the REIC protein, without which cancer cells can not die.

“MTG-201 directly attacks mesothelioma cancer cells and induces immune system response, and may be used in combination with anti–CTLA-4 therapies in development for the disease.

“In addition, MTG-201 is under development for the treatment of prostate cancer, and ongoing preclinical programs are evaluating MTG-201 as a potential treatment for liver and bladder cancers.”


Pembrolizumab Promised Fast FDA Action on Frontline Melanoma Indication

“Pembrolizumab (Keytruda) has received priority review from the US Food and Drug Administration (FDA) as frontline treatment for patients with advanced melanoma, according to Merck, the manufacturer of the anti–PD-1 checkpoint inhibitor. A final decision is expected from the FDA by December 19, 2015.

“In a separate action, the FDA delayed its decision date on an application for pembrolizumab in ipilimumab-refractory advanced melanoma to December 24, 2015, based on the need to review additional data submitted by Merck.

“ ‘Through our clinical program for KEYTRUDA we have accumulated substantial data on the role of our anti–PD-1 therapy in advanced melanoma. We look forward to the FDA’s review of each of these applications, and to delivering on our goal of helping patients with advanced melanoma to achieve long-term disease control and survival,’ said Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories.”


FDA Delays Decision for Frontline Nivolumab

“The review period for frontline nivolumab (Opdivo), in patients who have advanced melanoma, recently received an extension of 3 months by the FDA, in order to allow ample time for review of the additional data submitted by Bristol-Myers Squibb (BMS). The updated action date for the new indication is November 27, 2015.

“Nivolumab initially received a priority review designation for the new indication on April 30, 2015, based on the phase III CheckMate-066 trial that explored nivolumab in untreated patients with BRAF wild-type advanced melanoma. The new data hope to support an approval that is irrespective of BRAF status, BMS indicated.

“ ‘The CheckMate-066 trial marked the first time that a PD-1 immune checkpoint inhibitor showed a survival benefit in a randomized phase III trial,’ Michael Giordano, MD, senior vice president, Head of Development, Oncology, BMS, said when the FDA initially accepted the application. ‘We look forward to continuing to work with the FDA to ensure cancer patients are provided the latest clinical advances that have the potential for improved responses and long-term survival.’ “


FDA Approves Iressa for EGFR Metastatic Lung Cancer

“Iressa (gefitinib) has been approved by the U.S. Food and Drug Administration to treat patients with metastatic non-small-cell lung cancer (NSCLC) with a specific genetic mutation (epidermal growth factor receptor [EGFR]). A just-approved companion diagnostic test can identify patients who could benefit from this new use.

“Iressa is a kinase inhibitor, a class of drugs designed to block proteins that spur development of cancer cells. The therascreen EGFR RGQ PCR Kit is a newly approved diagnostic that can help doctors detect patients with the genetic mutation who are candidates for treatment with Iressa.

“Iressa was evaluated for this use in clinical trials involving 106 people with previously untreated EGFR mutation-positive metastatic NSCLC. Tumors shrank in about 50 percent of people treated with Iressa 250 mg once daily. This effect lasted an average of six months, the FDA said. Severe side effects of Iressa may include interstitial lung disease, liver damage, gastrointestinal perforation, severe diarrhea, and ocular disorders. More common side effects are diarrhea and skin reactions.”


UPDATE 1-Lilly Cancer Drug Improves Survival, Raises Blood Clot Risk -FDA

“Eli Lilly & Co.’s experimental lung cancer drug necitumumab improved overall survival by an average of 1.6 months but also increased the risk of sometimes fatal blood clots, according to a preliminary review by the U.S. Food and Drug Administration.

“The FDA’s review was posted on its website on Tuesday ahead of July 9 meeting of outside experts who will discuss the drug and recommend whether it should be approved. The FDA usually follows the advice of its advisory panels.

“Necitumumab is a second-generation monoclonal antibody for patients with stage IV squamous non-small cell lung cancer.

“In a 1,093-patient clinical trial patients who received necitumumab together with the chemotherapy drugs gemcitabine and cisplatin survived an average of 11.5 months compared with 9.9 months for patients who received gemcitabine and cisplatin alone.”