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Oncology Times:
doi: 10.1097/01.COT.0000453329.83016.80
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ONS14 Congress Report: New Drug Update

DiGiulio, Sarah

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ANAHEIM, Calif.—Teresa Knoop, MSN, RN, AOCN, began the annual “New Drug Update” session here at the Oncology Nursing Society's 39th Annual Congress by comparing the session with a similar one she had moderated at the meeting 10 years ago when it was also held in Anaheim. “We talked about three new drugs then—We've come a long way.”

There is now much excitement about harnessing the immune system to fight cancer, said Knoop, Assistant Director of Clinical Trials Shared Resource at Vanderbilt-Ingram Comprehensive Cancer Center. She predicted “a huge revolution coming.” Drugs are and have been in development for the treatment of melanoma and renal cell cancers, and are expanding into lung and other cancers, too.

“Now, though, is the time of targeted therapies,” she added—and spent much of the talk discussing those targeted therapies.

TERESA KNOOP, MSN, RN, AOCN
TERESA KNOOP, MSN, RN, AOCN
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Molecularly Targeted Agents

Knoop noted the following molecularly targeted agents approved by the FDA in 2013 and so far in 2014 (prior to her talk in early May) for cancer treatment:

  • Pomalidomide (Pomalyst) was approved for the treatment of patients with multiple myeloma who have received at least two prior therapies that have included lenalidomide and bortezomib, and after having disease progression on or within 60 days of completion of last therapy (OT 3/10/13);
  • Ado-trastuzumab emtansine (T-DM1) (Kadcyla) was approved for the treatment of patients with HER2-positive metastatic breast cancer who have previously received trastuzumab and a taxane, separately or in combination, for metastatic disease, or have developed disease recurrence during or within six months of completing adjuvant therapy (OT 3/25/13 issue);
  • Dabrafenib (Tafinlar) was approved as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test (OT 6/25/13 issue);
  • Trametinib (Mekinist) was also approved as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test (OT 6/25/13 issue);
  • Afatinib (Gilotrif) was approved as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations as detected by an FDA-approved test (OT 8/10/13 issue);
  • Obinutuzumab (Gazyva) was approved to be used in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (OT 12/10/13 issue);
  • Ibrutinib (Imbruvica) was approved for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy (OT 12/10/13 issue), and for the treatment of patients with chronic lymphocytic leukemia after at least one prior therapy (OT 3/10/14 issue);
  • Ofatumumab (Arzerra) was approved for the treatment of previously untreated patients with chronic lymphocytic leukemia (OT 5/10/14 issue); and
  • Trametinib (Mekinist) and dabrafenib (Tafinlar) were approved to be used in combination for the treatment of patients with unresectable or metastatic melanoma who harbor a BRAF V600E or V600K mutation (OT 2/10/14 issue).

She also noted seven molecularly targeted therapies that gained FDA-approved indications in 2013 for cancer treatment:

  • Bevacizumab (Avastin) is now approved for the treatment of patients with metastatic colorectal cancer, to be used with a fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy after progression on a first-line bevacizumab-containing regimen (OT 2/25/13 issue);
  • Regorafenib (Stivarga) is now approved for use in locally advanced, unresectable or metastatic gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate (OT 3/25/13 issue);
  • Erlotinib (Tarceva) is now approved for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (OT 6/10/13 issue);
  • Denosumab (Xgeva injection) is now approved for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity (OT 7/10/13 issue);
  • Lenalidomide capsules (REVLIMID) are now approved for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (OT 7/10/13 issue);
  • Pertuzumab injection (Perjeta) is now approved for use in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early stage breast cancer (OT 11/10/13 issue); and
  • Sorafenib (Nexavar) is now approved for the treatment of patients with radioactive iodine-resistant metastatic differentiated thyroid cancer (OT 12/25/13 issue).
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Other Approvals

She also discussed these additional cancer agents approved by the FDA in 2013 and to date in 2014:

  • Radium 223 dichloride (Xofigo injection) was approved for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease (OT 6/10/13 issue);
  • Ramucirumab (Cyramza) was approved as a single agent for the treatment of advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after being treated with a fluoropyrimidine or platinum containing regimen (OT 5/25/14 issue);
  • Ceritinib (Zykadia) was approved as a single agent for the treatment of patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib (OT 5/25/14 issue); and
  • Siltuximab (Sylvant) was approved as a single agent for the treatment of patients with multicentric Castleman's disease who are HIV and HHV-8 negative (OT 5/25/14 issue).
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Other New Indications

Two cytotoxic drugs received new FDA-approved indications or a new generic form in 2013:

  • Paclitaxel protein-bound particles (albumin-bound) (Abraxane) was approved for use in combination with gemcitabine for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas (OT 10/10/13 issue); and
  • Doxorubicin hydrochloride liposome injection (a generic form of Doxil) was approved for the treatment of ovarian cancer that has progressed or recurred after platinum-based chemotherapy and for AIDS-related Kaposi's sarcoma after failure or intolerance to prior systemic chemotherapy (OT 3/25/13 issue).

Read continuing coverage of oncology-related FDA news on OT's Online First blog on oncology-times.com and in this Collection: http://bit.ly/OT-FDANewsCollection

ThisOncology Timesregular insert series is edited byOTAssistant Editor Sarah DiGiulio

Wolters Kluwer Health | Lippincott Williams & Wilkins

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