Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates

April turned out to be a productive month in terms of drug approvals, with the FDA issuing positive verdicts on almost all applications for which decisions were due. The month saw the approval of five new molecular entities, which are drugs with active ingredients that have not been approved previously.

Immunomedics, Inc. IMMU received an early approval, as its Trodelvy was approved for previously treated, metastatic, triple-negative breast cancer, ahead of its June 2 PDUFA date.

Here are the key FDA decisions due for the unfolding month.

Can Bristol-Myers Breathe Easy With Approval of IO Combo In First-line Lung Cancer Setting?

• Company: Bristol-Myers Squibb Co BMY
• Type of Application: sBLA
• Candidate: Opdivo+Yervoy
• Indication: Lung cancer
• Date: May 15

The company is seeking approval for the combo regimen to treat patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

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Clovis Eyes Rubraca Approval For Prostate Cancer Drug

• Company: Clovis Oncology Inc CLVS
• Type of Application: sNDA
• Candidate: Rubraca
• Indication: prostate cancer
• Date: May 15

The FDA accepted Jan. 15 the sNDA for Rubraca as a monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer. Rubraca has already been approved for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Aquestive's Partnered Parkinson's Disease Drug Under FDA Scanner

• Company: Aquestive Therapeutics Inc AQST
• Type of Application: NDA
• Candidate: apomorphine sublingual film (APL-130277)
• Indication: To treat off episodes in Parkinson's disease patients
• Date: May 21

Apomorphine sublingual film is a novel formulation of apomorphine, a dopamine agonist, being developed as a fast-acting on-demand treatment of OFF episodes associated with Parkinson's disease, by Sunovion Pharmaceuticals, a subsidiary of Sumitomo Dainippon Pharma. It's being evaluated in partnership with Aquestive.

In January 2019, the drug faced rejection at the FDA altar, with the FDA seeking additional information and analyses but no additional clinical studies. Sunovion resubmitted the application in December 2019.

Can Second Time Be Charm For Evofem?

• Company: Evofem Biosciences Inc EVFM
• Type of Application: NDA
• Candidate: Amphora
• Indication: contraceptive
• Date: May 25

Amphora is an investigational multipurpose vaginal pH regulator designed to raise the vaginal pH within the normal range of 3.5 to 4.5, making the environment inclement for sperm as well as some viral and bacterial pathogens associated with sexually-transmitted infections.

Evofem has submitted the original NDA for Amphora in July 2015, and was handed down a CRL by the FDA in April 2016 on the pretext of variance in the results between the U.S. and Russian cohorts.

The company resubmitted the NDA in November 2019, with the FDA acknowledging the receipt of it and classifying it as a Class 2 resubmission.

Can Regeneron/Sanofi's Dupixent Snag Another Label Expansion?

• Company: Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY
• Type of Application: sBLA
• Candidate: Dupixent
• Indication: Pediatric eczema
• Date: May 26

The BLA was accepted for review with Priority Application status by the FDA Jan 28. Regeneron and Sanofi are seeking a label expansion for the drug as an add-on maintenance treatment for children, ages 6-11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Dupixent has already been approved for eczema in people, 12 years and older, as an add-on maintenance therapy for asthma in people, 12 years and older, as well as an add-on therapy for treat chronic rhinosinusitis with nasal polyposis in adults.

AstraZeneca, Merck's Partnered Cancer Drug Up Before FDA For Label Expansion

• Company: AstraZeneca plc AZN and Merck & Co., Inc. MRK
• Type of Application: sNDA
• Candidate: Lynparza in combination with Roche Holdings AG's RHHBY Avastin
• Indication: Ovarian cancer
• Date: second quarter

AstraZeneca and Merck announced FDA acceptance of the sNDA on Jan. 13. Assuming the application was filed 60 days prior to the acceptance, estimated PDUFA date is likely to be May 12. The FDA is mandated to communicate to the sponsor of the drug its decision to accept or refuse the filing within 60 days of the receipt of the application.

The companies are seeking approval for the Lynparza combo therapy as a maintenance treatment of patients with ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab.

Lynparza is a PARP inhibitor that has already been approved for the treatment of advanced ovarian cancer, metastatic breast cancer and metastatic pancreatic cancer.

J&J's Janssen Seeks Approval for New Formulation of Blood Cancer Drug

• Company: Johnson & Johnson's JNJ Janssen unit
• Type of Application: BLA
• Candidate: new subcutaneous formulation of Darzalex
• Indication: Multiple myeloma
• Date: July (estimated based on the BLA filing date of July 12, 2019)

Darzalex was licensed by Janssen from GENMAB A/S/S ADR GMAB under a 2012 agreement. The subcutaneous formulation of is co-formulated with recombinant human hyaluronidase PH20 used in Halozyme Therapeutics, Inc.'s HALO ENHANZE drug delivery technology.

An intravenous formulation of Darzalex was initially approved by the FDA in 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy.