News

Hyman Muss, MD, discusses special considerations that should be taken when treating older patients with HER2-positive or triple-negative breast cancer.

Understanding of the role of BCL-2 in acute myeloid leukemia (AML) continues to evolve, even as BCL-2–targeted therapy improves outcomes in the disease, AML specialist Daniel Pollyea, MD, MS said at the 2017 Society of Hematologic Oncology Annual Meeting in Houston, Texas.

Based on phase III results from the PROSELICA trial, the FDA has approved the combination of cabazitaxel at a dose of 20 mg/m² every 3 weeks and prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who previously received a docetaxel-containing regimen.

Amit G. Singal, MD, MS, stressed that improvement for precision screening for hepatocellular carcinoma with the current screening techniques through its risk-stratifying approach.

Hepatocyte pERK-positive immunostaining and microvascular invasion were independent prognostic factors of recurrence-free survival for patients with hepatocellular carcinoma treated with adjuvant sorafenib. According to an analysis of the phase III STORM study presented at the 11th International Liver Cancer Association Annual Conference, a predictive biomarker for recurrence was not uncovered.

According to updated phase III results presented at the 11th Annual International Liver Cancer Association Conference, first-line therapy with Lenvatinib in the frontline setting continued to be noninferior in overall survival and achieve significant improvements in progression-free survival, time to progression, and objective response rate versus sorafenib for patients with unresectable hepatocellular carcinoma

Direct acting antivirals, a novel, oral hepatitis C therapy, is associated with a high response rate. DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis. However, this treatment has been replaced by interferon-based therapy for patients with hepatitis C.

According to findings presented at the 11th Annual Conference on the International Liver Cancer Association in Seoul, South Korea, BLU-554 induced an overall response rate of 16% in patients with FGF 19 immunohistochemistry-positive hepatocellular carcinoma. BLU-554 is a potent and highly selective inhibitor of fibroblast growth factor receptor 4.

Excitement surrounds systemic therapies for hepatocellular carcinoma, with 1 new drug recently approved, 2 agents pending FDA decisions, and later-stage clinical trials for multiple therapies on the horizon.

Today, ABP-215, a biosimilar for bevacizumab developed by Amgen and Allergan, received FDA approval for the treatment of several different cancer types, making it the first biosimilar approved for the treatment of cancer.

Based primarily on findings from the phase II CHRONOS-1 trial, copanlisib (Aliqopa) has received an accelerated approval from the FDA as a treatment for patients with relapsed follicular lymphoma who have received at least 2 prior systemic therapies.

Paul A. Bunn, MD, discusses why pseudoprogression and hyperprogression are concerns when treating patients with immunotherapy, and weighed in on what to do in each situation.

An investigational RET inhibitor demonstrated clinical activity in a subgroup of patients with RET fusion-positive non&ndash;small cell lung cancer (NSCLC), according to data from a phase Ib trial reported at the ESMO Annual Congress in Madrid.<br /> &nbsp;

CMB305, an immunotherapy regimen that generates and expands anti-NY-ESO-1 T cells, demonstrated a favorable survival rate in patients with recurrent soft tissue sarcoma, compared with other agents approved for the disease.

Adding ramucirumab to docetaxel improved progression-free survival (PFS) over docetaxel alone for patients with advanced or metastatic urothelial carcinoma who have progressed on platinum-based chemotherapy,&nbsp;results from the international phase III RANGE trial showed.

Pembrolizumab has been approved by the European Commission for the treatment of patients with locally advanced or metastatic urothelial carcinoma&nbsp;who have received prior platinum-containing chemotherapy, or who are not eligible for cisplatin-containing chemotherapy.

An overall response rate of 61% was induced by adding the IDO inhibitor indoximod to pembrolizumab in patients with advanced melanoma, according to updated results presented at the International Cancer Immunotherapy Conference in Frankfurt/Mainz, Germany.

Based on findings of the randomized CheckMate-236 trial, nivolumab may be a less toxic, better tolerated adjuvant treatment option over&nbsp;ipilimumab for patients with&nbsp;resected stage IIIB/C and IV melanoma, whether or not they have a <em>BRAF</em> mutation.

A biologics license application for the rituximab biosimilar Rixathon has been accepted by the FDA, according to Sandoz, the company developing the treatment.&nbsp;If it receives approval, rixathon would be indicated for&nbsp;follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia, as well as for rheumatoid arthritis.

Multiple trials in Celgene&rsquo;s FUSION program, which is exploring regimens combining the PD-L1 inhibitor durvalumab (Imfinzi) with immunomodulatory and chemotherapy agents across several hematologic malignancies,&nbsp;have been placed on clinical holds by the FDA.

Partial clinical holds have been placed on 3 trials by the FDA, which are assessing nivolumab (Opdivo)-based combinations in patients with relapsed/refractory multiple myeloma.

Tumor shrinkage was induced in women with ER-positive metastatic breast cancer who had progressed on standard anti-estrogen therapies with treatment with&nbsp;Z-endoxifen, a potent derivative of the drug tamoxifen.

A look back at all the FDA news that occurred in the month of August.

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.