Microinvasive Endobronchial Non-Small-Cell Lung Cancer (NSCLC)

The role of PDT with PHOTOFRIN® (porfimer sodium) for injection1

PHOTOFRIN® is indicated for treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated.

Potential patient types include1

  • Patients with microinvasive lung cancer, a tumor that invades beyond the basement membrane of the bronchial wall, but not into the cartilage
  • Patients may be ineligible for surgery or radiotherapy due to:
    • Prior high-dose radiotherapy
    • Poor pulmonary function
    • Multifocal multilobar disease
    • Poor medical condition

Tumor Response Rate1

In 3 noncomparative studies the complete tumor response rate at least 3 months (biopsy-proven) after treatment was 50% for 62 inoperable patients. For the 11 patients (out the 62 inoperable patients where it was documented that surgery and radiotherapy were not indicated), the complete tumor response rate was 27%.

A course of PDT therapy consisted of one injection of PHOTOFRIN® (2 mg/kg administered as a slow intravenous injection over 3 to 5 minutes) followed by up to 2 non-thermal applications of 630 nm laser light. Light doses of 200 J/cm of diffuser length were used. For 11 of the 62 patients, it was clearly documented that surgery and radiotherapy were not indicated. These 11 patients were all inoperable for medical or technical reasons. Radiotherapy was not indicated due to prior high-dose radiotherapy (7 patients), poor pulmonary function (2 patients), multifocal multilobar disease (1 patient), and poor medical condition (1 patient). The complete tumor response rate, biopsy-proven at least 3 months after treatment, was 50%.

†Does not include additional 18 patients (6 not eligible for surgery or radiotherapy) who had complete tumor responses documented earlier than 3 months after treatment.

Adverse Reactions Reported in 5% or More of Patients‡ with Superficial Endobronchial Tumors1

Three patients experienced life-threatening dyspnea: one was given a double dose of light, one was treated concurrently in both mainstem bronchi and the other had prior pneumonectomy and was treated in the sole remaining main airway.1‡

  • Stent placement was required in 3% of the patients due to endobronchial stricture1
  • Fatal massive hemoptysis occurred within 30 days of treatment in one patient with superficial tumors (1%)1

Important Safety Information and Indication

Contraindications

  • PHOTOFRIN® is contraindicated in patients with porphyria
  • Photodynamic Therapy (PDT) is contraindicated in patients with an existing tracheoesophageal or bronchoesophageal fistula
  • PDT is contraindicated in patients with tumors eroding into a major blood vessel
  • PDT is not suitable for emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion because 40 to 50 hours are required between injection with PHOTOFRIN® and laser light treatment
  • PDT is not suitable for patients with esophageal or gastric varices, or patients with esophageal ulcers >1 cm in diameter

Warnings and Precautions

  • Tracheoesophageal or bronchoesophageal fistula can occur if esophageal tumor is eroding into trachea or bronchial tree
  • Gastrointestinal perforation can occur
  • High risk of bleeding in patients with esophageal varices
  • High risk for fatal massive hemoptysis with endobronchial tumors that are: large, centrally located; cavitating; extensive, extrinsic to the bronchus
  • After treatment of high-grade dysplasia (HGD) in Barrett’s esophagus (BE), monitor endoscopic biopsy every three months, until four consecutive negative evaluations for HGD have been recorded
  • Photosensitivity can be expected; ocular sensitivity is possible
  • Allow 2-4 weeks between PDT and subsequent radiotherapy
  • Substernal chest pain may occur after treatment
  • Treatment induced inflammation can cause airway obstruction. Administer with caution to patients with tumors in locations where treatment-induced inflammation can obstruct the main airway
  • Esophageal stenosis occurs frequently after treatment of HGD in BE
  • Patients with hepatic or renal impairment may need longer precautionary measures for photosensitivity
  • Thromboembolic events can occur following photodynamic therapy with PHOTOFRIN®
  • Embryo-Fetal Toxicity: May cause embryo-fetal toxicity. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Adverse Reactions

Most common adverse reactions reported during clinical trials (>10% of patients) are:

  • Esophageal Cancer: Anemia, pleural effusion, pyrexia, constipation, nausea, chest pain, pain, abdominal pain, dyspnoea, photosensitivity reaction, pneumonia, vomiting, insomnia, back pain, pharyngitis
  • Obstructing Endobronchial Cancer: Dyspnoea, photosensitivity reaction, hemoptysis, pyrexia, cough, pneumonia
  • Superficial Endobronchial Tumors: Exudate, photosensitivity reaction, bronchial obstruction, edema, bronchostenosis
  • High-Grade Dysplasia in Barrett’s Esophagus: Photosensitivity reaction, esophageal stenosis, vomiting, chest pain, nausea, pyrexia, constipation, dysphagia, abdominal pain, pleural effusion, dehydration

These are not all the possible side effects of PHOTOFRIN®. For more information call your healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Pinnacle Biologics, Inc. at 1-866-248-2039.

PHOTOFRIN® is indicated for:

Esophageal Cancer

  • Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy

Endobronchial Cancer

  • Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated
  • Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC

High-Grade Dysplasia in Barrett’s Esophagus

  • Ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy

Please see accompanying full Prescribing Information for Photofrin®

References: 1. PHOTOFRIN® (porfimer sodium for injection) [package insert]. Bannockburn, IL: Pinnacle Biologics.