A Look Back at the FDA News from August 2021

Here is a look back FDA happenings from July 2021.

In August 2021, the FDA granted 2 approvals for the treatment of renal cell carcinoma. Other cancer types that received FDA approved treatment include IDH1-mutant cholangiocarcinoma, solid tumors, and bladder cancer.

In addition to approvals, the FDA granted 2 orphan drug designations, 6 priority review applications, and 4 fast track designations. However, eflapegrastim for chemotherapy-induced neutropenia and vicinium for the treatment of Bacillus Calmette-Guerin-unresponsive non-muscle invasive bladder cancer were denied approvals.

FDA Grants Fast Track Designation to Mucosal Melanoma Treatment Nemvaleukin Alfa

At the start of August, the FDA granted a fast track designation for nemvaleukin alfa (ALKS 4230), an interleukin-2 variant immunotherapy, for the treatment of mucosal melanoma, according to a press release by Alkermes plc.

FDA Grants Priority Review to BLA for Adjuvant Atezolizumab in PD-L1+ NSCLC

On August 3, the FDA accepted the supplemental biologics license application submitted for atezolizumab as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer whose tumors express PD-L1 ≥1%, as determined by an FDA-approved test and granted it priority review.

FDA Grants Priority Review to Pembrolizumab for Stage IIB or IIC Melanoma

The FDA accepted and granted priority review to a biologics license application for pembrolizumab for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection on August 5.

FDA Grants Orphan Drug Status to Sotigalimab for Patients With Soft Tissue Sarcoma

An orphan drug designation was granted on August 5 to the CD40 agonistic monoclonal antibody, sotigalimab, for the treatment of patients with soft tissue sarcoma.

Eflapegrastim Still Not Approved by FDA After New Complete Response Letter

The FDA issued a complete response letter on August 6 to the developer of eflapegrastim, for which a biologics license application was submitted for the treatment of chemotherapy-induced neutropenia. The FDA has cited manufacturing deficiencies and is requiring that the facilities be reinspected.

FDA Grants Priority Review to sBLA for Adjuvant Pembrolizumab in RCC

On August 10, the FDA accepted supplemental biologics license application for adjuvant pembrolizumab and granted it priority review as a treatment for patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

FDA Accepts sBLA for Pembrolizumab Monotherapy for Endometrial Cancer

The FDA accepted a new supplemental biologics license application for pembrolizumab, an anti-PD-1 therapy, as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have diseased progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation on August 10.

FDA Releases New Guidance on MFS as a Primary End Point for Prostate Cancer Trials

On August 11, the FDA announced metastasis-free survival can be an effective end point in clinical trials to support approval of castration-resistant prostate cancer therapies under certain conditions when overall survival is not feasible as an end point.

FDA Approval Decision Pending on Cabozantinib as a New Treatment Option for RR-DTC

Progression-free survival was significantly prolonged with cabozantinib as treatment of patients with radioiodine-refractory differentiated thyroid cancer in the phase 3 COSMIC-311 clinical trial, showing potential as a new treatment option and leading to the filing of a application for FDA approval on August 11.

FDA Approves Frontline Pembrolizumab and Lenvatinib Combination for Advanced RCC

The FDA granted approval to the combination of pembrolizumab (Keytruda) and lenvatinib (Lenvima) for the first-line treatment of adult patients with advanced renal cell carcinoma on August 11.

FDA Grants Breakthrough Therapy Designation to Toripalimab Combination in Nasopharyngeal Carcinoma

On August 12, the FDA granted breakthrough therapy designation to toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.

FDA Approves Belzutifan for Von-Hippel Lindau-Associated RCC

On August 13, the FDA approved belzutifan for the treatment of Von-Hippel Lindau-associated renal cell carcinoma treated in frontline setting.

FDA Does Not Approve Vicinium for BCG-unresponsive NMIBC

The FDA issued a complete response letter on August 16 to Sesen Bio, denying the approval of the Biologics License Application for Vicinium for the treatment of BCG-unresponsive non-muscle invasive bladder cancer.

FDA Grants Fast Track Designation to IN10018 FAK Inhibitor for Ovarian Cancer

On August 16, the FDA granted a fast-track designation to IN10018, a selective ATP-competitive focal adhesion kinase small molecule inhibitor, for the treatment of platinum-resistant ovarian cancer.

FDA Grants Accelerated Approval to Dostarlimab for Solid Tumors

The FDA granted an accelerated approval on August 17 to dostarlimab-gxly (Jemperli), a programmed cell death receptor-1 blocking antibody, for the treatment of adult patients with mismatch repair-deficient recurrent or advanced solid tumors that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

FDA Grants Fast Track Designation to STRO-002 for Ovarian Cancer

On August 18, the FDA granted a fast track designation to the folate receptor alpha-targeting antibody-drug conjugate, STRO-002, for the treatment of patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior lines of systemic therapy.

FDA Grants Fast Track Designation to Silmitasertib for SHH-Driven Medulloblastoma

The FDA granted a fast track designation to the highly selective inhibitor of casein kinase 2 inhibitor, silmitasertib for the treatment of patients with recurrent sonic hedgehog-driven medulloblastoma on August 19.

Dostarlimab-Gxly Diagnostic Panel Ventana MM RRxDx Panel Granted FDA Approval

The FDA approved the Ventana MMR RxDx Panel on August 19, a companion diagnostic test to determine which patients with DNA mismatch repair deficiency are likely to benefit from the anti-PD-1 monotherapy dostarlimab-gxly.

FDA Approves Adjuvant Nivolumab for Surgically Resected, High-Risk Bladder Cancer

On August 20, the FDA granted approval to nivolumab as an adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.

FDA Grants Priority Review to Abatacept to Prevent Moderate to Severe Acute GVHD

On August 23, the FDA accepted the supplemental biologics license application for abatacept and granted it priority review for the prevention of moderate to severe acute graft versus host disease in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation.

FDA Grants Priority Review to STAMP Inhibitor Asciminib for Ph+ CML

Asciminib for the treatment of 2 chronic myeloid leukemia subgroups is now under FDA consideration for approval as of August 25.

FDA Approves Ivosidenib Tablets for IDH1-Mutant Cholangiocarcinoma

On August 25, the FDA approved iIvosidenib Tablets for the treatment of patients with IDH1-mutant cholangiocarcinoma.

FDA Grants Priority Review to Tebentafusp for Uveal Melanoma Treatment

The FDA accepted the biologics license application for tebentafusp on August 25 and granted it priority review for the treatment of adult patients with HLA-A*02:01-positive metastatic uveal melanoma.

FDA Approves Ivosidenib CDx for IDH1-Mutated Cholangiocarcinoma Detection

To accompany a newly approved targeted therapy for IDH1-mutated cholangiocarcinoma, the Oncomine Dx Target Test has been approved as a companion diagnostic as of August 26.

FDA Grants Orphan Drug Designation to LP-184 for Malignant Gliomas

The FDA granted orphan drug designation to the small molecule and next-generation alkylating agent, LP-184, for the treatment of patients with glioblastoma multiforme and other malignant gliomas on August 31.