Cancer Drugs and Treatments Approved by the FDA in 2014

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Drug companies kept Dr. Richard Pazdur and the Office of Oncology Drug Products at the US Food and Drug Administration busy in 2014. In all they granted 18 approvals, although some approvals merely expanded the label of previously approved drugs to include new indications. Accelerated approval was granted to five new drugs.

The cancer subtypes affected by this year's approvals include:

  • Melanoma
  • Ovarian cancer
  • Pancreatic neuroendocrine tumors
  • Non-small cell lung cancer
  • Acute lymphoblastic lymphoma
  • Chronic lymphocytic leukemia
  • Gastric adenocarcinoma
  • Multicentric Castleman's disease
  • Peripheral T-cell lymphoma
  • Cervical cancer
  • Primary peritoneal cancer

2014 FDA Cancer Drug Approvals

DRUG: Combination trametinib (Mekinist) and dabrafenib (Tafinlar)
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with unresectable or metastatic melanoma with a BRAAF V600E or V600K mutation.

DRUG: Ibrutinib (Imbruvica)
APPROVAL TYPE: Accelerated
INDICATION: Treatment of patients with chronic lymphocytic leukemia (CLL) with a history of at least one prior therapy.

DRUG: Ofatumumab (Arzerra) in combination with chlorambucil
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is not appropriate.

DRUG: Ramucirumab (Cyramza)
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma.

DRUG: Siltuximab (Sylvant)
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with multicentric Castleman disease who are HIV negative and HHV-8 negative.

DRUG: Mercaptopurine (Purixan) in oral suspension in combination with other drugs.
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with acute lymphoblastic leukemia (ALL).

DRUG: Ceritinib (Zykadia)
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer who are intolerant to crizotinib.

DRUG: Belinostat (Beleodaq)
APPROVAL TYPE: Accelerated
INDICATION: Patients with relapsed or refractory peripheral T-cell lymphoma.

DRUG: Idelalisib (Zydelig) in combination with rituximab
APPROVAL TYPE: Standard
INDICATION: Patients with relapsed CLL for whom rituximab alone would be considered appropropriate therapy because of existing comorbidities.

DRUG: Bevacizumab solution for IV infusion (Avastin) in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
APPROVAL TYPE: Standard
INDICATION: Patients with persistent, recurrent, or metastatic cervical cancer.

DRUG: Pembrolizumab (Keytruda)
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with unrsectable or metastatic melanoma and disease progression following ipilimunab and, if BRAF V600 mutation positive, a BRAF inhibitor.

DRUG: Ramucirumab (Cyramza)
APPROVAL TYPE: Standard
INDICATION: Expanded use to including using it in combination with paclitaxel for the treatment of patients with advanced gastric or GEV adenocarcinoma.

DRUG: Bevacizumab solution for IV infusion (Avastin) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan.
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

DRUG: Blinatumomab (Blincyto)
APPROVAL TYPE: Accelerated
INDICATION: Treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell ALL.

DRUG: Ruxolitinib (Jakafi)
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with polycythemia vera who had an inadequate response or are intolerant to hydroxyurea.

DRUG: Ramucirumab (Cyramza) in combination with docetaxel
APPROVAL TYPE: Standard
INDICATION: Treatment for patients with non small cell lung cancer with disease progression on or after receiving platinum-based chemotherapy.

DRUG: Lanreotide (Somatuline Depot)
APPROVAL TYPE: Standard
INDICATION: Treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

DRUG: Olaparib (Lynparza)
APPROVAL TYPE: Accelerated
INDICATION: Treatment of patients with advanced ovarian cancer associated with defective BRCA genes.

DRUG: Nivolumab (Opdivo)
APPROVAL TYPE: Accelerated
INDICATION: Treatment of patients with unresectable or metastatic melanoma who no longer respond to other treatments.

 

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