News

The decision deadline on a biologics license application (BLA) for MYL-1401O, a trastuzumab (Herceptin) biosimilar co-developed by Mylan and Biocon, has been extended by 3 months, the FDA has announced. Under the new timeframe, a final decision is expected on or before December 3, 2017.

<br /> Cancer biologist Ramon Parsons, MD, PhD, was recently named director of the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai.

The FDA recently released a statement providing specific data from 2 phase III trials placed on hold in July investigating pembrolizumab (Keytruda) in multiple myeloma.

A supplemental new drug application seeking to add overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib (Kyprolis) for use in patients with relapsed or refractory multiple myeloma has been accepted by the FDA.

A supplemental new drug application for bosutinib (Bosulif) has been granted a priority review by the FDA for the first-line treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia. The agency is scheduled to make a final decision by December 2017.<br /> &nbsp;

A historic approval of the first chimeric antigen receptor (CAR) T-cell therapy has been issued by the FDA, authorizing the use of tisagenlecleucel (Kymriah) for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse.

Jane McElroy, PhD, discusses the association between higher cadmium levels and an increased risk of endometrial cancer.

Overall survival was improved for women with cervical cancer by adding bevacizumab (Avastin) to chemotherapy, according to final results from the phase III GOG 240 trial published online in <em>The Lancet</em>.

The FDA has granted breakthrough therapy designation to the investigational HER2-targeting antibody-drug conjugate DS-8201 for the treatment of patients with HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab (Herceptin) and pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla).

A supplemental biologics license application for obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, has been granted a priority review by the FDA for the first-line treatment of patients with follicular lymphoma.

Breast cancer expert Carlos Arteaga, MD, was recently named director of the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern Medical Center.

Results from a recent retrospective study published in the<em> Journal of Clinical Oncology</em>^&nbsp;revealed hospice enrollment is low and use of aggressive treatment is high for elderly patients with acute myeloid leukemia.

According to results from a trial conducted by investigators from the Children&rsquo;s Oncology Group, treatment with arsenic trioxide consolidation was effective and safe in newly diagnosed pediatric patients with acute promyelocytic leukemia, allowing a significant reduction in cumulative anthracycline doses.

Eunice Wang, MD, discusses a study examining the biology of newly diagnosed patients with <em>FLT3</em>-positive acute myeloid leukemia who achieved a response to the FLT3 TKI crenolanib combined with chemotherapy.

Fulvestrant (Faslodex) has been approved by the FDA for use in hormone receptor-positive, HER2-negative locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

Jonathan E. Rosenberg, MD, discusses the muscle-invasive bladder cancer guidelines&nbsp;and their significance for the treatment of patients with muscle-invasive bladder cancer.

Carfilzomib (Kyprolis) reduced the risk of death by 21% compared with bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, according to results from the phase III ENDEAVOR trial, now published in the<em> Lancet Oncology.</em>

The CDK 4/6 inhibitor ribociclib (Kisqali) has been approved by the European Commission for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor (HR)&ndash;positive, HER2-negative locally advanced or metastatic breast cancer.

Antonia R. Sepulveda, MD, PhD, discusses&nbsp;the importance and utility of genetic testing in GI cancers, as well as noteworthy developments in microsatellite instability, <em>BRAF</em>, and <em>KRAS </em>testing in colorectal cancer.

Robert Andtbacka, MD, discusses&nbsp;long-term results for T-VEC in melanoma and the remaining challenges with the oncolytic immunotherapy.<br /> &nbsp;

Manuel Hidalgo, MD, shares his insight on the growth of genetic testing in CRC.<br /> &nbsp;

Patients with intermediate- or high-risk gastrointestinal stromal tumors were less likely to experience recurrence after 5 years of treatment with imatinib, according to results from the phase II PERSIST-5 trial.

Frankie Ann Holmes, MD, discusses which breast cancer patients can benefit from endocrine therapy and the challenges that still exist with deciding between chemotherapy and endocrine therapy for each patient.

Investigators recently reported 5-year follow-up data from a phase II study of dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with <em>BRAF</em> V600-mutant unresectable or metastatic melanoma.

In patients with heavily-pretreated microsatellite stable metastatic colorectal cancer (mCRC), treatment with CEA-TCB, an investigational CEA/CD3 bispecific antibody, showed a favorable safety profile and promising efficacy, with enhanced efficacy when combined with the PD-L1 inhibitor atezolizumab.

The FDA has granted its approval to olaparib tablets (Lynparza) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy, regardless of <em>BRCA</em> status.

Inotuzumab ozogamicin (Besponsa) has received FDA approval for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), based on findings from the phase III INO-VATE trial.

Dominik P. Modest, MD, discusses a retrospective, central evaluation of the FIRE-3 study to determine surgical treatment options, which explored the number of patients with metastatic colorectal cancer who had resectable disease during systemic first-line therapy.&nbsp;

A supplemental biologics license application (sBLA) for brentuximab vedotin (Adcetris) has been granted a priority review by the FDA for the treatment of patients with cutaneous T-cell lymphoma (CTCL), according to Seattle Genetics, which codevelops the antibody-drug conjugate with Takeda.

Exelixis has submitted a supplemental New Drug Application to the FDA for the multikinase inhibitor cabozantinib as treatment for previously untreated patients with advanced renal cell carcinoma.