Oncology Drugs Approved by the FDA in Early 2018

June 2018 Vol 11, No 4 - FDA Approvals, News & Updates
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Lynparza First Treatment for Patients with BRCA-Positive Metastatic Breast Cancer

On January 12, 2018, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca) for the treatment of women with deleterious or suspected deleterious germline BRCA-positive, HER2-negative, metastatic breast cancer after receiving chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is the first FDA-approved treatment for this patient population. Like other PARP inhibitors, olaparib was previously approved for the treatment of ovarian cancer.

This approval was based on results showing a median progression-free survival (PFS) of 7 months with olapa­rib versus 4.2 months with chemotherapy alone (95% confidence interval [CI], 0.43-0.80; P = .0009). On the same day, the FDA approved the BRAC­Analysis CDx test to identify patients with breast cancer and deleterious or suspected deleterious germline BRCA mutations who may be eligible for treatment with olaparib.

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Gilotrif Approved for First-Line Treatment of Metastatic NSCLC

On January 12, 2018, the FDA approved afatinib (Gilotrif; Boehringer Ingelheim) as first-line treatment of metastatic non–small-cell lung cancer (NSCLC) and nonresistant EGFR mutations as identified by an FDA­approved test. Afatinib was previously approved for patients with metastatic NSCLC and EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and for patients with metastatic squamous NSCLC that progressed with platinum-based chemotherapy.

This approval was based on durable responses in 32 patients with metastatic NSCLC and nonresistant EGFR mutations other than exon 19 deletions or exon 21 L858R substitutions. The overall response rate (ORR) was 66% (95% CI, 47-81); among the 21 patients who responded to treatment, the response lasted ≥12 months in 52% of patients and ≥18 months in 33% of patients.

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Lutathera First Radioactive Drug Approved for Neuroendocrine Tumors

On January 26, 2018, the FDA approved lutetium Lu 177 dotatate (Lutathera; Advanced Accelerator Applications), a radioactive drug, for the treatment of adults with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first radioactive drug approved for GEP-NETs. This drug works by binding to a somatostatin receptor on the tumor, using the radiation to destroy cancer cells.

This approval was based on the results of 2 clinical trials that showed improved PFS and a 16% complete or partial response rate with lutetium Lu 177 dotatate. Serious side effects include myelosuppression, secondary myelodysplastic syndrome, leukemia, renal toxicity, hepatotoxicity, neuroendocrine hormonal crises, and infertility. Patients receiving lutetium Lu 177 dotatate are exposed to radiation, which may cause harm.

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Zytiga Approved for High-Risk Metastatic Castration-Sensitive Prostate Cancer

On February 7, 2018, abiraterone acetate (Zytiga; Janssen Biotech) received FDA approval, in combination with prednisone, for high-risk metastatic castration-sensitive prostate cancer (CSPC). This is the first drug approved for metastatic CSPC.

The abiraterone acetate plus prednisone combination was previously approved for metastatic castration-resistant prostate cancer (CRPC) after chemotherapy and for newly diagnosed metastatic CRPC. This approval was based on results showing the median overall survival was not reached with the combination versus 34.7 months with placebo (P <.0001); the median time to chemotherapy initiation was also not reached with the combination versus 38.9 months with placebo (P <.0001).

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Erleada First Therapy Approved for Nonmetastatic Prostate Cancer

On February 14, 2018, apalutamide (Erleada; Janssen), an androgen receptor inhibitor, received accelerated approval for nonmetastatic CRPC. Apalutamide is the first treatment approved for nonmetastatic CRPC.

The approval was based on data showing median metastasis-free survival of 40.5 months with apalutamide versus 16.2 months with placebo.

The common (≥10%) side effects reported with apalutamide include fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flushes, decreased appetite, fractures, and peripheral edema.

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Imfinzi First Treatment to Reduce Progression in Unresectable Stage III NSCLC

On February 16, 2018, the FDA approved an expanded indication for durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for unresectable stage III NSCLC that did not progress after chemoradiation.

This new indication was based on data showing a median PFS of 16.8 months with durvalumab versus 5.6 months with placebo. The overall survival rates are still awaiting postmarketing results from clinical trials.

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Verzenio Approved as Initial Treatment for Metastatic Breast Cancer

On February 26, 2018, the FDA approved a new indication for abemaciclib (Verzenio; Eli Lilly), a CDK4/CDK6 inhibitor, alone or in combination with an aromatase inhibitor, as initial endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer.

Abemaciclib was previously approved as monotherapy for HR-positive, HER2-negative advanced or metastatic breast cancer.

This new indication was based on updated results showing a median PFS of 28.2 months with abemaciclib plus an aromatase inhibitor versus 14.8 months with placebo (P <.0001). The median duration of response was 27.4 months with abemaciclib versus 17.5 months with placebo (95% CI, 25.7-NR vs 11.2-22.2, respectively).

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Adcetris Approved as Initial Treatment for Advanced Hodgkin Lymphoma

On March 20, 2018, the FDA approved a new indication for brentuximab vedotin (Adcetris; Seattle Genetics) as a first-line treatment, in combination with chemotherapy, for adults with untreated stage III or stage IV classical Hodgkin lymphoma.

This new indication was based on results from the ECHELON-1 clinical trial of 1334 treatment-naïve patients with stage III or IV classical Hodgkin lymphoma that compared brentuximab vedotin plus chemotherapy versus chemotherapy alone. After an average of six 28-day cycles, patients who received brentuximab vedotin plus chemotherapy had a 23% reduced mortality risk, started a new treatment, or had disease progression versus those who received chemotherapy alone.

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Blincyto Approved for B-Cell ALL with Minimal Residual Disease

On March 29, 2018, the FDA accelerated the approval of a new indication for blinatumomab (Blincyto; Amgen) for B-cell precursor acute lymphoblastic leukemia (ALL) in patients in remission but at risk for relapse because of minimal residual disease (MRD). Blinatumomab was previously approved for relapsed or refractory B-cell precursor ALL.

This new approval was based on results showing that of 86 patients with detectable MRD, treatment with blinatum­omab resulted in undetectable MRD in 70 patients, and >50% of them were still in remission after ≥22.3 months.

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Rubraca Approved for Maintenance Treatment of 3 Gynecologic Cancers

On April 6, 2018, the FDA approved a new indication for the PARP inhibitor rucaparib (Rubraca; Clovis Oncology) for maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients reaching complete or partial response with chemotherapy. On the same day, the FDA also approved FoundationFocus CDxBRCA LOH, a next-generation sequencing assay, for the identification of HRD mutation, a new somatic mutation found in <10% of ovarian cancers.

In 2016, rucaparib was approved for advanced ovarian cancer after ≥2 chemotherapies.

The new indication is based on results showing that the median PFS in all patients was 10.8 months with rucaparib versus 5.4 months with placebo, and 13.6 months versus 5.4 months, respectively, in the HRD subgroup. In all, 15% of patients receiving rucaparib and 2% of those receiving placebo discontinued treatment because of adverse events.

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Opdivo plus Yervoy Approved as First-Line Treatment for Renal-Cell Cancer

On April 16, 2018, the FDA approved the combination of nivolumab (Opdivo; Bristol-Myers Squibb) and ipilimumab (Yervoy; Bristol-Myers Squibb) as first-line treatment of intermediate- or poor-risk advanced renal-cell carcinoma.

This approval was based on a study comparing nivolumab plus ipilimumab followed by nivolumab alone, versus sunitinib alone.

The median overall survival was not reached with the combination and was 25.9 months with sunitinib. The ORR was 41.6% with the combination versus 26.5% with sunitinib.

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Tagrisso Approved as First-Line Therapy for Metastatic NSCLC and EGFR Mutation

On April 18, 2018, the FDA approved osimertinib (Tagrisso; AstraZeneca) as first-line treatment for metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

This new indication was based on a study comparing osimertinib 80 mg daily versus gefitinib 250 mg or erlotinib 150 mg daily. The median PFS was 18.9 months with osimertinib versus 10.2 months with gefitinib or erlotinib. The ORR was 77% with osimertinib and 69% with gefitinib or erlotinib, and the median response duration was 17.6 months and 9.6 months, respectively. Not enough deaths occurred to assess survival outcomes.

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