ASCO 2015 Highlights

Tabrecta Receives Regular FDA Approval for Treatment of Metastatic NSCLC
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On August 10, 2022, the FDA accelerated the regular full approval of capmatinib (Tabrecta; Novartis), a tyrosine kinase inhibitor, for the treatment of metastatic non–small-cell lung cancer (NSCLC) in adults whose tumors have MET exon 13 skipping mutation, as detected by an FDA-approved test.
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Retevmo Approved for Locally Advanced or Metastatic RET Fusion–Positive Solid Tumors and Locally Advanced or Metastatic RET Fusion– Positive NSCLC
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On September 21, 2022, the FDA accelerated the approval of selpercatinib (Retevmo; Eli Lilly), a RET kinase inhibitor, for the treatment of locally advanced or metastatic solid tumors with a RET gene fusion in patients whose disease has progressed while or after receiving systemic treatment or who have no alternative treatment options.
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Imfinzi Receives New Indication for Locally Advanced or Metastatic Biliary Tract Cancer
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On September 2, 2022, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca), a PD-L1–blocking antibody, in combination with gemcitabine and cisplatin, for the treatment of locally advanced or metastatic biliary tract cancer in adults.
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Pemazyre Now Approved for Relapsed or Refractory Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On August 26, 2022, the FDA accelerated the approval of pemigatinib (Pemazyre; Incyte Corporation), a tyrosine kinase inhibitor, for the treatment of relapsed or refractory myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR)1 rearrangement in adults.
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Imbruvica Now Approved for Treatment of Pediatric Patients with Chronic GVHD, Including New Oral Suspension Formulation
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On August 24, 2022, the FDA accelerated the approval of ibrutinib (Imbruvica; Pharmacyclics), a Bruton tyrosine kinase inhibitor, for the treatment of chronic graft-versus-host disease (GVHD) in pediatric patients aged ≥1 years who have not responded to ≥1 lines of systemic treatment.
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Enhertu First Drug Approved for HER2-Positive Non–Small- Cell Lung Cancer
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On August 11, 2022, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a human epidermal growth factor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, for the treatment of unresectable or metastatic non–small-cell lung cancer (NSCLC) in adults whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have previously received systemic therapy.
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FDA Accelerates the Approval of Enhertu for the Treatment of HER2-Low Breast Cancer
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On August 5, 2022, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a human epidermal growth factor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, for the treatment of unresectable or metastatic HER2-low (immunohistochemistry [IHC]1-positive or IHC2-positive/in situ hybridization–negative) breast cancer in adults who have previously received chemotherapy in the metastatic setting or who have had disease recurzrence during or within 6 months of completing adjuvant chemotherapy.
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Nubeqa Now Approved for Metastatic Hormone- Sensitive Prostate Cancer
FDA Approvals, News & Updates
October 2022, Vol 13, No 5
On August 5, 2022, the FDA accelerated the approval of darolutamide (Nubeqa; Bayer Healthcare), an androgen receptor inhibitor, in combination with docetaxel, for the treatment of metastatic hormone-sensitive prostate cancer in adults. Darolutamide was previously approved for the treatment of nonmetastatic castration-resistant prostate cancer.
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Relapsed or Refractory FL: Best Practices for Active Surveillance & Reinforcement of Management Plans
Relapsed/Refractory Follicular Lymphoma
Relapsed or Refractory FL: Best Practices for Active Surveillance & Reinforcement of Management Plans
By Tycel J. Phillips, MD; Peg Rummel, MHA, RN, OCN, NE-BC; Andrew D. Zelenetz, MD, PhD
Interview with the Innovators
Videos
Drs Tycel Phillips and Andrew Zelenetz discuss best practices around implementing active surveillance (AS) after initial diagnosis of follicular lymphoma (FL). Ms Peg Rummel comments on the role of oncology nurses – including nurse navigators - in enhancing the acceptance of an AS approach by FL patients, as well as reinforcing a dynamic plan of care in patients who experience relapses or harbor treatment-refractory disease.
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Predicting High-Risk Disease Using Progression of Disease in 24 Months (POD24) and the Key Role of Repeat Biopsy to Exclude the Diagnosis of Transformation to a High-Grade Lymphoma in Patients with Relapsed Follicular Lymphoma
Relapsed/Refractory Follicular Lymphoma
Predicting High-Risk Disease Using Progression of Disease in 24 Months (POD24) and the Key Role of Repeat Biopsy to Exclude the Diagnosis of Transformation to a High-Grade Lymphoma in Patients with Relapsed Follicular Lymphoma
By Tycel J. Phillips, MD; Peg Rummel, MHA, RN, OCN, NE-BC; Andrew D. Zelenetz, MD, PhD
Interview with the Innovators
Videos
Dr Andrew Zelenetz explains the basis for the currently nearly universal use of the end point of “progression of disease in 24 months” (POD24) as a metric in patients with relapsed follicular lymphoma (FL) to identify a high-risk subpopulation. He also discusses how POD24 impacts the choice of therapy and assessing the impact of the next line of therapy. Dr Tycel Phillips emphasized the importance of repeat biopsy in patients with relapsed or refractory FL, to exclude the presence of histologic transformation of FL into a high-grade diffuse large B-cell lymphoma, which necessitates expeditious detection, staging, and aggressive therapy.
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