US FDA approval tracker: November 2021

The FDA dished out three Pdufa extensions and four knockbacks in November, including a CRL for Beyondspring’s plinabulin in chemotherapy-induced neutropenia. Beyondspring said today that the FDA had requested a second clinical study of plinabulin; this news sent the company's shares down 55% in early trading and follows disappointing NSCLC data at Esmo. On the flip side, Biomarin’s Voxzogo gained accelerated approval in patients aged five and older with achondroplasia. Assessing final adult height is part of the post-marketing requirement and Biomarin has said it will use the ongoing open-label extension studies versus natural history for confirmatory data. Merck’s Keytruda also gained another string to its bow last month with an adjuvant approval in renal cell cancer. The decision came three weeks early and puts Keytruda further ahead of rivals, which will start reporting phase 3 data next year.

Notable first-time US approval decisions in November
Project Company Indication(s) 2026e SBI ($m) Outcome
Ciltacabtagene autoleucel

Johnson & Johnson/
Legend Biotech
3L+ multiple myeloma 1,692 Extended to Feb 28 (updated analytical method)
Biomarin Achondroplasia 720 Approved (accelerated)
(risperidone ISM)
Laboratorios Farmacéuticos ROVI Schizophrenia 375 CRL (manufacturing inspection)
CTI Biopharma Myelofibrosis patients with severe thrombocytopenia 368 Extended to Feb 28
(data submission)
Takeda Post-transplant cytomegalovirus infection in those that are refractory, with or without resistance 355 Approved
Amryt Epidermolysis bullosa 269 Extended to Feb 28 (review of additional data analyses)
Erwinaze Clinigen/
Porton Biopharma
ALL patients who have developed hypersensitivity to E. coli-derived asparaginase 211 CRL
Takeda Eosinophilic oesophagitis 188 No decision yet
Pedmark Fennec Cisplatin-induced ototoxicity for paediatric patients 165 CRL
(manufacturing deficiencies)
Opko Health/
VBI Vaccines
Hepatitis B 164 Approved
Plinabulin + G-CSF Beyondspring Prevention of chemotherapy-induced neutropenia  138 CRL
(more data requested)
Yutrepia (LIQ861
/treprostinil inhalation powder)
Liquidia Pulmonary arterial hypertension 126 Tentative approval*
pafolacianine sodium injection)
On Target Laboratories Adjunct for identifying ovarian cancer during surgery - Approved
Eprontia (topiramate oral solution
Azurity Pharmaceuticals/
Eton Pharmaceuticals
Tonic-clonic seizures, partial-onset seizures, and as preventative treatment of migraine - Approved
Besremi (ropeginterferon alfa-2b) Pharmaessentia Polycythemia vera - Approved
Aadi Bioscience Advanced malignant PEComa - Approved
Epsolay Sol-Gel Papulopustular rosacea - No decision yet
*Final FDA approval may occur in Oct 2022 or earlier upon resolution of ongoing litigation with United Therapeutics. SBI=sales by indication, CMC=chemistry, manufacturing and controls.
Source: Evaluate Pharma & company releases.


Advisory committee meetings in November
Project Company Indication Outcome
(intranasal carbetocin)
Levo Hyperphagia, anxiety, and distress behaviours associated with Prader-Willi syndrome 12-1 against approval
Molnupiravir Merck/
EUA for the treatment of mild to moderate Covid-19 in adults who are at risk for progressing to severe Covid-19 and/or hospitalisation 13-10 for EUA
Source: FDA adcom calendar, Evaluate Pharma.


Supplementary and other notable approval decisions in November
Product Company Indication (clinical trial) Outcome
Dyanavel XR tablets Tris Pharma ADHD Approved
Keytruda  Merck Adjuvant treatment of RCC at intermediate-high or high risk of recurrence (Keynote-564 Approved
(3 weeks early)
(Avastin biosimmilar)
Bio-Thera Solutions Metastatic colorectal cancer (+ chemo), 1L non-squamous NSCLC, recurrent glioblastoma, met renal cell carcinoma (+ interferon alfa), persistent, recurrent or met cervical cancer No decision yet
Source: Evaluate Pharma & company releases. 

Share This Article