A Look Back at the FDA News from May 2021


Here is a look back at the FDA happenings from the month of May 2021.

Seven oncologic drugs were approved by the FDA in May 2021, adding to the treatment paradigm of gastric and gastroesophageal cancer, non–small cell lung cancer, prostate cancer, and cholangiocarcinoma. Multiple applications for approval were also submitted to the FDA in May with plans to change the practice for treating neuroendocrine tumors, non–small cell lung cancer, chronic lymphocytic leukemia, and more.

May was also a month during which several breakthrough therapy and orphan drug designations were granted to investigational agents designed for the treatment of cancer.

Here is a look back at the FDA happenings from the month of May 2021:

FDA Approval Sought for Surufatinib in Pancreatic and Extra-Pancreatic NETs

On May 4, a rolling submission of a new drug application to the FDA was initiated for surufatinib (previously HMPL 012) as a potential treatment option for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

FDA Grants Priority Review to Ivosidenib Tablets for IDH1-Mutant Cholangiocarcinoma

The FDA accepted a supplemental new drug application for ivosidenib tablets and granted it priority review on May 5, for the treatment of patients with previously treated IDH1-mutated cholangiocarcinoma.

FDA Approves 1L Pembrolizumab Combination in Locally Advanced Unresectable or Metastatic HER2+ Gastric/GEJ Cancers 

On May 5, the FDA also granted accelerated approval to pembrolizumab (Keytruda) in combination with trastuzumab (Herceptin), fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma.

FDA Grants Priority Review to Pembrolizumab Plus Lenvatinib in Advanced RCC and Endometrial Cancer

The FDA granted priority review to 2 supplemental new drug applications on May 6 for the combination use of pembrolizumab (Keytruda) and lenvatinib (Lenvima) as treatment of both patients with advanced renal cell carcinoma in the frontline setting and as treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

FDA Grants Orphan Drug Status to BOLD-100 For the Treatment of Gastric Cancer

On May 11, the FDA granted orphan drug designation to the first-in-class ruthenium-based small molecule, BOLD-100, for the treatment of patients with gastric cancer.

FDA Lifts Partial Clinical Hold on Study of Odronextamab in FL and DLBCL

Regeneron announced on May 17, that enrollment of patients with follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) in monotherapy trial of odronextamab (formerly REGN19179) will be resumed after the FDA lifted the partial clinical hold placed on the agent in December 2020.

FDA to Review BLA for Frontline Sintilimab/Pemetrexed in Nonsquamous NSCLC

On May 18, the FDA accepted a biologics license application for sintilimab (Tyvyt) injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with nonsquamous non-small cell lung cancer.

FDA Accepts sNDA for Zanubrutinib for Marginal Zone Lymphoma

The FDA accepted a supplemental new drug application for zanubrutinib (Brukinsa) on May 19, for the treatment of adult patients with marginal zone lymphoma who have received 1 prior anti-CD20-based therapy. The agent was also granted priority review, with a Prescription Drug User Fee Act target action date of September 19, 2021.

FDA Grants Fast Track Designation to Novel CAR T-Cell Therapy for Thyroid Cancers

On May 19, the FDA also granted a fast track designation to the autologous chimeric antigen receptor T-cell agent, AIC100, for the treatment of patients with anaplastic thyroid cancer and refractory poorly differentiated thyroid cancer.

FDA Approves Adjuvant Nivolumab for Resected Esophageal/GEJ Cancer

The FDA granted approval to adjuvant nivolumab (Opdivo) on May 20, for the treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy.

FDA Approves Amivantamab for Frontline EGFR Exon 20-Positive NSCLC

On May 24, the FDA granted approval to amivantamab-vmjw for the frontline treatment of adult patients with non-small cell lung cancer whose tumors have EGFR exon 20 insertion mutations, according to a press release issued by the FDA.

FDA Approval Sought for Penpulimab for Third-Line Metastatic Nasopharyngeal Carcinoma

A biologics license application was submitted to the FDA on May 24, for the PD-1 monoclonal antibody drug penpulimab for the third-line treatment of metastatic nasopharyngeal carcinoma.

FDA Grants BTD to VS-6766 With Defactinib for Recurrent Low-Grade Serous Ovarian Cancer

On May 24, the FDA granted breakthrough therapy designation to the combination of VS-6766, an investigational RAF/MEK inhibitor and defactinib (VS-6063), a FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer regardless of KRAS status after 1 or more lines of therapy, including platinum-based chemotherapy.

FDA Accepts BLA for Ublituxumab and Umbralisib for Chronic Lymphocytic Leukemia

The FDA accepted the biologic license application for ublituximab (TGTX-1101) in combination with umbralisib (Ukoniq) on May 25, for the treatment of patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

FDA Approves Piflufolastat for Detection of Metastasis and Recurrence in Prostate Cancer

On May 27, the FDA granted approval to piflufolastat F 18 (Pylarify) injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, to identify patients who may have metastasis or recurrence of prostate cancer.

FDA Approves Sotorasib for KRAS G12C+ Locally Advanced or Metastatic NSCLC

The FDA granted accelerated approval to sotorasib (Lumakras) on May 28, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

FDA Grants Accelerated Approval of Infigratinib for FGFR2+ Cholangiocarcinoma

On May 28, the FDA also granted accelerated approval to the oral FGFR1-3 selective inhibitor, infigratinib (Truseltiq) for the treatment of patients with cholangiocarcinoma who harbor an FGFR2 gene fusion or rearrangement.

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